[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658663":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":36,"studyPopulation":36,"armGroups":43,"interventions":71,"overallOfficials":36,"centralContacts":36,"locations":81,"responsibleParty":95,"collaborators":97,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":36,"eligibilityCriteria":106,"healthyVolunteers":103,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":36,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":36,"overallStatus":119,"whyStopped":36,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Jiangsu Famous Medical Technology Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"PFS","assessed by an Independent Review Committee (IRC) and using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1","one year after enrollment",[14,18,20,23,26,29,33],{"measure":15,"description":16,"timeFrame":17},"DCR","assessed by an Independent Review Committee (IRC)","1 year",{"measure":19,"description":16,"timeFrame":17},"ORR",{"measure":21,"description":22,"timeFrame":17},"Degree of cancer-related fatigue","investigator-assessed using the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) scale. FACIT-F is a patient-reported outcome scale containing 13 items. Respondents answer each item based on their fatigue experience in the past 7 days with a 5-point Likert scale. Reverse scoring is applied to positively phrased items before total score calculation. The total score ranges from 0 (minimum) to 52 (maximum). Higher FACIT-F scores indicate less fatigue and better functional status, while lower scores indicate more severe fatigue. This scale is widely validated for chronic disease populations including cancer patients. It is used in clinical trials to quantitatively assess fatigue symptoms and functional impairment, and to evaluate changes in fatigue before and after intervention.",{"measure":24,"description":25,"timeFrame":17},"Degree of myelosuppression","investigator-assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)",{"measure":27,"description":28,"timeFrame":17},"Quality of life","investigator-assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) .EORTC QLQ-C30 is a patient-reported outcome questionnaire with 30 items, developed to assess health-related quality of life in cancer patients. It includes 5 functional scales, 3 symptom scales, single symptom items, and a global health status \u002F quality of life scale. Subjects respond according to their condition during the past week. After standard scoring transformation, each scale score ranges from 0 (minimum) to 100 (maximum).For functional scales and the global health status scale: higher scores represent better function and higher quality of life. For symptom scales and single symptom items: higher scores indicate more severe symptoms.",{"measure":30,"description":31,"timeFrame":32},"Traditional Chinese Medicine (TCM) syndromes","investigator-assessed - Survey Scale of TCM Syndromes in Advanced Colorectal Cancer","At each scheduled study visit until the end of the study at 12 months.",{"measure":34,"description":35,"timeFrame":17},"TCM symptom assessment","investigator-assessed using the MD Anderson Symptom Inventory for Traditional Chinese Medicine (MDASI-TCM).MDASI-TCM is a patient-reported outcome instrument, consisting of the core MDASI symptom items plus supplementary traditional Chinese medicine symptom items. Subjects rate the severity of each symptom over the past 24 hours using a 0-10 numeric rating scale, where 0 represents \"not present\" and 10 represents \"as bad as you can imagine\". The total composite score ranges from 0 (minimum) to 10 (maximum) for each symptom item. Higher scores mean more severe symptoms and greater symptom disturbance; lower scores indicate milder symptoms. This scale has been validated in cancer patients for combined western and TCM symptom assessment. It is applied in clinical trials to quantify symptom burden and evaluate the effect of interventions on symptom relief.",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":36,"whoMasked":36},"NONE",[44,50,54,59,63,67],{"label":45,"type":46,"description":47,"interventionNames":48},"RCT1","EXPERIMENTAL","Treatment-naïve for metastatic colorectal cancer; randomized via IWRS central randomization (1:1 allocation, stratified by primary tumor location \\[left-sided \u002F right-sided colon-rectum\\] and presence\u002Fabsence of liver metastasis).\n\nChemotherapy: Investigator-selected first-line systemic chemotherapy for metastatic colorectal cancer.\n\nFor intervention group ：Chemotherapy +Zhen-Qi-Jie-Du Granules Formula-Ⅰ：2 small sachets, twice daily, taken after breakfast and dinner. Maximum intended duration: up to 6 months; early discontinuation allowed per protocol-defined stopping criteria.\n\nFor control group :Only Chemotherapy. No Zhen-Qi-Jie-Du Granules are administered. No other anti-tumor Chinese patent medicine, herbal decoction or injectable TCM anti-tumor agents are permitted during study treatment.\n\nAssessments: Tumor evaluation every 8 weeks (for 2-week chemotherapy cycles) or every 6 weeks (for 3-week chemotherapy cycles) ±7-day window",[49],"Drug: Zhen-Qi-Jie-Du Granules I",{"label":51,"type":46,"description":52,"interventionNames":53},"OBS-1","Population: First-line MSS metastatic colorectal cancer patients who refuse randomization and enter observational cohort. No random allocation.\n\nChemotherapy: Investigator-selected first-line chemotherapy (same regimen menu as RCT1 arms) Zhen-Qi-Jie-Du Granules Formula-Ⅰ: Whether to take is at the subject's own discretion.",[49],{"label":55,"type":46,"description":56,"interventionNames":57},"RCT2","randomized via IWRS central randomization (1:1 allocation, stratified by primary tumor location \\[left-sided \u002F right-sided colon-rectum\\] and presence\u002Fabsence of liver metastasis).\n\nChemotherapy: Investigator-selected second-line systemic chemotherapy for metastatic colorectal cancer.\n\nFor intervention group ：Chemotherapy +Zhen-Qi-Jie-Du Granules Formula-II：2 small sachets, twice daily, taken after breakfast and dinner. Maximum intended duration: up to 6 months; early discontinuation allowed per protocol-defined stopping criteria.\n\nFor control group :Only Chemotherapy. No Zhen-Qi-Jie-Du Granules are administered. No other anti-tumor Chinese patent medicine, herbal decoction or injectable TCM anti-tumor agents are permitted during study treatment.\n\nAssessments: Tumor evaluation every 8 weeks (for 2-week chemotherapy cycles) or every 6 weeks (for 3-week chemotherapy cycles) ±7-day window",[58],"Drug: Zhen-Qi-Jie-Du Granules II",{"label":60,"type":46,"description":61,"interventionNames":62},"OBS-2","Population: Second-line MSS metastatic colorectal cancer patients who refuse randomization and enter observational cohort. No random allocation.\n\nChemotherapy: Investigator-selected first-line chemotherapy (same regimen menu as RCT2 arms) Zhen-Qi-Jie-Du Granules Formula-II: Whether to take is at the subject's own discretion.",[58],{"label":64,"type":46,"description":65,"interventionNames":66},"RCT3","randomized via IWRS central randomization (1:1 allocation, stratified by primary tumor location \\[left-sided \u002F right-sided colon-rectum\\] and presence\u002Fabsence of liver metastasis).\n\nChemotherapy: Investigator-selected third-line systemic chemotherapy for metastatic colorectal cancer.\n\nFor intervention group ：Chemotherapy +Zhen-Qi-Jie-Du Granules Formula-II：2 small sachets, twice daily, taken after breakfast and dinner. Maximum intended duration: up to 6 months; early discontinuation allowed per protocol-defined stopping criteria.\n\nFor control group :Only Chemotherapy. No Zhen-Qi-Jie-Du Granules are administered. No other anti-tumor Chinese patent medicine, herbal decoction or injectable TCM anti-tumor agents are permitted during study treatment.\n\nAssessments: Tumor evaluation every 8 weeks (for 2-week chemotherapy cycles) or every 6 weeks (for 3-week chemotherapy cycles) ±7-day window",[58],{"label":68,"type":46,"description":69,"interventionNames":70},"OBS-3","Population: Third-line MSS metastatic colorectal cancer patients who refuse randomization and enter observational cohort. No random allocation.\n\nChemotherapy: Investigator-selected first-line chemotherapy (same regimen menu as RCT3 arms) Zhen-Qi-Jie-Du Granules Formula-II: Whether to take is at the subject's own discretion.",[58],[72,77],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":36},"DRUG","Zhen-Qi-Jie-Du Granules II","take Zhen-Qi-Jie-Du Granules II with Chemotherapy: 2 small sachets, twice daily, taken after breakfast and dinner. Maximum intended duration: up to 6 months; early discontinuation allowed per protocol-defined stopping criteria.",[60,68,55,64],{"type":73,"name":78,"description":79,"armGroupLabels":80,"otherNames":36},"Zhen-Qi-Jie-Du Granules I","take Zhen-Qi-Jie-Du Granules I with Chemotherapy: 2 small sachets, twice daily, taken after breakfast and dinner. Maximum intended duration: up to 6 months; early discontinuation allowed per protocol-defined stopping criteria.",[51,45],[82],{"facility":83,"status":36,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":36},"Jiangsu Province Hospital of Chinese Medicine","Nanjing","Jiangsu","210000","China","CN",{"type":90,"coordinates":91},"Point",[92,93],118.77778,32.06167,{"lat":93,"lon":92},{"type":96,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[98],{"name":99,"class":100},"Jiangsu Collaborative Innovation Center for Traditional Chinese Medicine Cancer Prevention and Treatment","UNKNOWN","100658663","a-clinical-study-on-the-synergistic-effects-of-zhen-qi-jie-du-granules-in-palliative-care-for-advanced-colorectal-cancer-100658663",false,"NCT07854405","A Clinical Study on the Synergistic Effects of Zhen-Qi-Jie-Du Granules in Palliative Care for Advanced Colorectal Cancer","Inclusion Criteria\n\nSubjects meeting all of the following criteria will be eligible to participate in this study:\n\n1. Patients with colorectal cancer who have a confirmed pathological diagnosis meeting the diagnostic criteria for the disease; patients with stage IV (MSS) colorectal cancer who are not candidates for curative surgery or who have a confirmed recurrence or metastasis post-surgery and are therefore ineligible for surgical treatment; and patients with at least one measurable lesion assessable according to RECIST 1.1 criteria.\n2. Have not received prior systemic therapy for metastatic disease (enrolment in the first-line sub-arm); have failed prior first-line treatment or discontinued treatment due to intolerable toxicity (enrolment in the second-line sub-arm); have failed prior second-line treatment or discontinued treatment due to intolerable toxicity (enrolment in the third-line sub-arm).\n3. Traditional Chinese Medicine (TCM) diagnosis consistent with TCM criteria for colorectal cancer (deficiency of both spleen and kidney, with internal obstruction by stasis and toxins).\n4. Expected survival of 3 months or more.\n5. Able to swallow, retain and absorb oral medication\n6. Aged 18-80 years; both men and women are eligible.\n7. ECOG performance status score of 0-1. Understand the details of this study, voluntarily agree to participate, and sign the informed consent form.\n\nNote: 1. For patients with early-stage disease (e.g. stages I-III) who have undergone surgery followed by chemotherapy (e.g. as part of adjuvant therapy), the emergence of new lesions or evidence of disease recurrence during treatment or within 6 months of its completion will be considered as receiving first-line treatment for metastatic disease.2. Patients who have previously received systemic neoadjuvant chemotherapy (including in combination with radiotherapy) and who develop new lesions or evidence of disease recurrence during treatment or within 6 months of its completion will be considered to be receiving first-line treatment for metastatic disease.\n\nExclusion Criteria\n\nA subject is ineligible for the study if they meet any of the following criteria:\n\n1. A history of other malignancies within the past five years (excluding basal cell carcinoma or squamous cell carcinoma of the skin treated with curative therapy, prostatic intraepithelial neoplasia, cervical carcinoma in situ, Bowen's disease, or prostate cancer with a Gleason score ≤6).\n2. Concurrent severe organic diseases affecting the cardiovascular, cerebrovascular, autoimmune, musculoskeletal, haematological, gastrointestinal, respiratory, immune, circulatory, reproductive, urinary or endocrine systems; clinically significant ECG abnormalities as assessed by the investigator; or abnormal liver or kidney function. (Normal liver and kidney function criteria: a. Serum total bilirubin ≤ 1.5 × ULN and \\\u003C 2 mg\u002FdL. If direct (conjugated) bilirubin is ≤ 1.5 times the upper limit of normal (ULN) and indirect (unconjugated) bilirubin is ≤ 4.25 times ULN, total bilirubin \\> 1.5 times ULN is permitted. b. ALT and AST ≤ 2.5 times ULN, or ≤ 5 times ULN in the presence of liver metastases.c. Estimated creatinine clearance ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula, or creatinine clearance determined via 24-hour urine collection, or according to the local institution's standard method.\n3. Impaired gastrointestinal function (e.g. uncontrolled nausea, vomiting or diarrhoea, malabsorption syndrome, small bowel resection) or conditions likely to significantly alter the absorption of the oral study intervention, or recent changes in bowel function suggestive of current or impending intestinal obstruction.\n4. Any unstable condition or condition that may jeopardise patient safety or compliance with the study, such as a desire to conceive, pregnancy, breastfeeding, or mental disorders including depression, bipolar disorder, obsessive-compulsive disorder, or schizophrenia.\n5. Individuals with an allergy to the components of this traditional Chinese medicine.\n6. Patients receiving other treatments prior to enrolment that may affect the efficacy assessment of this trial.\n7. Patients who have recently participated in or are currently participating in clinical trials of other drugs.\n8. Any other circumstances deemed unsuitable for inclusion by the investigator.","ALL","18 Years","80 Years",{"count":111,"type":112},1540,"ESTIMATED","INTERVENTIONAL",[115],"NA","The goal of this clinical trial is to learn whether Zhen-Qi-Jie-Du Granules combined with chemotherapy works to treat unresectable stage IV microsatellite-stable colorectal cancer in adults. It will also learn about the safety of Zhen-Qi-Jie-Du Granules when added to chemotherapy. The main questions it aims to answer are:\n\nDoes Zhen-Qi-Jie-Du Granules plus chemotherapy prolong progression-free survival compared with chemotherapy alone? Does Zhen-Qi-Jie-Du Granules improve disease control rate, objective response rate, cancer-related fatigue, myelosuppression, quality of life and traditional Chinese medicine syndrome for participants receiving chemotherapy? What medical problems and side effects do participants experience when taking Zhen-Qi-Jie-Du Granules alongside chemotherapy? Researchers will compare chemotherapy plus Zhen-Qi-Jie-Du Granules (intervention group) versus chemotherapy alone (control group). Participants may enter either a randomized controlled trial cohort or an observational cohort according to their own willingness.\n\nParticipants will:\n\nReceive investigator-selected first-line, second-line or third-line standard chemotherapy regimens for advanced colorectal cancer Take Zhen-Qi-Jie-Du Granules (2 sachets, twice daily after breakfast and dinner) if assigned to the intervention group, for up to 6 months (or until treatment discontinuation criteria are met) Attend clinic visits for physical examination, vital signs, ECOG performance status assessment, laboratory blood and urine tests, chest and abdominal CT\u002FMRI tumor imaging scans Complete validated questionnaires including FACIT-F, EORTC QLQ-C30, MDASI-TCM and the Late-Stage Colorectal Cancer TCM Syndrome Scale at scheduled visits Have adverse events, concomitant medications and survival status recorded throughout the study Provide plasma and stool biological samples at screening and scheduled follow-up visits Complete an End-of-Treatment (EOT) visit when stopping study treatment, regardless of the reason for discontinuation",[118],"Colorectal Cancer","NOT_YET_RECRUITING","2026-09-27",{"date":122,"type":123},"2026-10-02","ACTUAL",{"date":125,"type":112},"2026-09-30",{"date":127,"type":112},"2029-10-01",{"name":5,"class":6},1]