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:
Does 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.
Participants will:
Receive 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/MRI 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
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.
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).
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).
Expected survival of 3 months or more.
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).
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 < 2 mg/dL. 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/min using the Cockcroft-Gault formula, or creatinine clearance determined via 24-hour urine collection, or according to the local institution's standard method.
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.
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.
Parallel
Zhen-Qi-Jie-Du Granules II
Drugtake 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.
Zhen-Qi-Jie-Du Granules I
Drugtake 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.
6
Treatment groupsSee each treatment group below.
PFS
assessed by an Independent Review Committee (IRC) and using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1
DCR
assessed by an Independent Review Committee (IRC)
ORR
assessed by an Independent Review Committee (IRC)
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.
Degree of myelosuppression
investigator-assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Click on the lead sponsor to view all of their trials.
Jiangsu Famous Medical Technology Co., Ltd.
Lead sponsor
Jiangsu Collaborative Innovation Center for Traditional Chinese Medicine Cancer Prevention and Treatment
Collaborator
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