SHR-3821 in Advanced Colorectal Cancer: an Exploratory Study
ConditionColorectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMeng Qiu
About this trial
To evaluate the safety and efficacy of SHR-3821 combined with fruquintinib in the advanced colorectal cancer after failure of standard therapy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically confirmed unresectable recurrent or metastatic colorectal cancer.
Aged 18-75 years, male or female.
Failure of ≥2 lines of prior standard systemic therapy, which should have included oxaliplatin, irinotecan, and fluoropyrimidine-based chemotherapy. Subjects who failed first-line therapy are eligible if the first-line regimen contained all three chemotherapeutic agents, or if they exhibited intolerance or lack of response to oxaliplatin during adjuvant therapy. Subjects with dMMR/MSI-H tumors must also have failed anti-PD-1/PD-L1 antibody therapy.
Life expectancy ≥3 months.
Disqualifiers
Presence of concurrent active malignancies other than the primary tumor (except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder cancer, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and gastrointestinal tumors confirmed cured by endoscopic mucosal resection). History of prior malignancy is allowed if the disease has been cured for ≥2 years.
Patients with untreated or active central nervous system (CNS) metastases or leptomeningeal metastasis. Patients are eligible if they have received local therapy, have stable neurological symptoms for at least 2 weeks prior to the first dose, and do not require corticosteroids or require ≤10 mg/day of prednisone (or equivalent).
Presence of severe complications at the primary site (e.g., perforation, obstruction, uncontrollable massive hemorrhage).
Uncontrolled or moderate-to-large pleural effusion or pericardial effusion. Clinically symptomatic moderate or severe ascites (patients with small ascites detected only by imaging without clinical symptoms are eligible).
Trial design
Design model
Single group
Treatments tested in this trial
SHR-3821 and fruquintinib
DrugSHR-3821, administered by intravenous infusion Fruquintinib, administered orally
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: SHR-3821 combined with fruquintinibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of treatment related adverse event [Safety and Tolerability]
To identify the incidence of adverse events (AEs) and severe adverse events (SAEs) in clinical trial
Time frame
From the initiation of the first dose to 90 days after the last dose2
Objective response rate (ORR)
To evaluate the efficacy of anti-tumor
Time frame
From enrollment to the end of treatment at 6 weeksSecondary outcomes
1
Duration of Response (DOR)
To evaluate the efficacy of anti-tumor
Time frame
From enrollment to the end of treatment at 6 weeks2
Disease control rate (DCR)
To evaluate the efficacy of anti-tumor
Time frame
From enrollment to the end of treatment at 6 weeks3
Progression-free survival (PFS)
To evaluate the efficacy of anti-tumor
Time frame
From enrollment to the end of treatment at 12 weeks4
Overall survival (OS)
To evaluate the efficacy of anti-tumor
Time frame
From enrollment to the end of treatment at 12 mothsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Meng Qiu
Lead sponsor
West China Hospital
Sponsor institution
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: