Actively Recruiting
Irinotecan Plus Anlotinib or Further in Combination With Penpulimab for Second-line Treatment of mCRC
Led by Fudan University · Updated on 2024-07-03
44
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an exploratory, non-controlled, multi-cohort, phase II small-sample clinical study designed to evaluate the clinical benefit of second-line treatment with anlotinib plus irinotecan or further in combination with a PD-1 monoclonal antibody (penpulimab) in patients with advanced colorectal cancer after first-line treatment failure. To explore the rationality of the combination of chemotherapy and targeted therapy and immunotherapy strategy and obtain relevant survival and safety data. The study will fully evaluate the efficacy, PFS, OS, safety and related biomarkers of the regimen.
CONDITIONS
Official Title
Irinotecan Plus Anlotinib or Further in Combination With Penpulimab for Second-line Treatment of mCRC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with recurrent or metastatic colorectal adenocarcinoma confirmed by pathology
- Previously treated with first-line oxaliplatin and fluorouracil-based chemotherapy (with or without anti-EGFR or VEGF antibodies) and treatment failed
- Have at least one measurable tumor lesion meeting size requirements by CT scan
- Known KRAS, NRAS, BRAF, and MSI status with wild-type BRAF; MSS/pMMR status required for Cohort A
- ECOG performance status score of 0 or 1
- Life expectancy of at least 12 weeks
- Recovered from effects of prior anti-tumor therapy for at least 4 weeks and wounds fully healed
- Adequate bone marrow, liver, and kidney function within 7 days before screening
- Women of childbearing age agree to use effective contraception
- Willing to participate and sign informed consent with good compliance and follow-up
You will not qualify if you...
- History of other cancers within 5 years except treated cervical carcinoma in situ or basal cell carcinoma
- Uncontrolled hypertension or significant heart conditions including arrhythmia and cardiac dysfunction
- Symptomatic brain or meningeal metastases unless stable and treated for over 6 months
- Uncontrolled pleural or abdominal effusion
- Undergoing kidney dialysis
- Severe or uncontrolled infection
- Pregnant or breastfeeding without adequate contraception
- Conditions affecting oral medication intake like swallowing problems or intestinal obstruction
- Abnormal blood clotting or bleeding tendencies, or recent gastrointestinal bleeding risk
- Prior treatment with irinotecan or anti-PD-1/PD-L1/other immune checkpoint therapies
- Prior use of anti-VEGFR small molecule inhibitors including anlotinib
- Participation in other drug clinical trials within 4 weeks
- Significant proteinuria on urine tests
- Use of immunosuppressive agents within 4 weeks before study (with exceptions)
- Residual liver volume less than 50% of total liver volume
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
C
Chenchen Wang, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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