Actively Recruiting
Adebrelimab Combined With Famitinib Malate and Irinotecan Versus Irinotecan in Patients With Advanced Gastric Cancer After Failure of First-Line Therapy: A Randomized, Controlled, Exploratory Clinical Study
Led by Shandong Tumor Hospital · Updated on 2025-12-30
66
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Adebrelimab with Famitinib and Irinotecan in patients with advanced gastric or gastroesophageal junction adenocarcinoma who have failed first-line systemic chemotherapy and immune checkpoint inhibitor treatments. This randomized, controlled, exploratory clinical trial aims to study the safety and effectiveness of this combination compared to Irinotecan alone. The study includes a safety run-in period followed by an extended treatment phase based on initial safety findings. During the initial safety run-in phase, 6 patients receive Adebrelimab combined with Famitinib and Irinotecan to monitor for dose-limiting toxicities over the first treatment cycle. If safety criteria are met, an additional 60 patients are randomized 1:1 into either the experimental group receiving Adebrelimab plus Famitinib and Irinotecan, or the control group receiving Irinotecan alone. Treatments are administered every three weeks and continued until disease progression, unacceptable toxicity, death, or withdrawal. Participants undergo regular assessments including evaluation of tumor response using RECIST v1.1 criteria and monitoring of adverse events for up to two years. The primary outcome is progression-free survival measured from enrollment to disease progression or death. Secondary outcomes include overall survival, disease control rate, and safety recorded through the study and 90 days post-treatment. Participants are followed closely with laboratory tests and clinical evaluations throughout the study period.
CONDITIONS
Brief Title
Adebrelimab Combined With Famitinib and Irinotecan in Advanced Gastric Cancer After Failure of First-Line Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology
- Patients who have failed first-line treatment including systemic chemotherapy and immune checkpoint inhibitors, with at least 3 months of immune checkpoint inhibitor use
- At least one measurable lesion per RECIST v1.1, not previously treated locally or confirmed progression if previously irradiated
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Adequate organ function with blood, liver, and kidney tests meeting specified thresholds
- Use of medically approved contraception during treatment and for 6 months after last Adebrelimab or chemotherapy dose for those with fertility
- Voluntary informed consent, good compliance, and willingness to participate in follow-up
You will not qualify if you...
- History of gastrointestinal perforation or fistula within 6 months before treatment
- Uncontrollable pleural, pericardial, or peritoneal effusion needing repeated drainage
- Allergies to components of Adebrelimab
- Recent investigational drug use or participation in other clinical trials
- Anti-tumor therapy or corticosteroids (>10mg prednisone daily) within 2 weeks before study drug
- Anti-tumor or live vaccines within 4 weeks before study drug
- Major surgery or severe trauma within 4 weeks before study drug
- Previous treatment with paclitaxel drugs
- Unresolved toxicity from previous anti-tumor treatments above grade 1 (except hair loss)
- Active central nervous system metastases
- Active or history of autoimmune diseases requiring intervention
- Immune deficiency, HIV positive, organ or bone marrow transplant history, or active hepatitis
- Uncontrolled cardiovascular diseases or symptoms
- Severe infection or active pulmonary inflammation recently
- History of interstitial lung disease or active pulmonary tuberculosis
- Other malignant tumors diagnosed within 5 years except certain low-risk types
- Pregnant or breastfeeding women
- Other serious illnesses or factors judged to interfere with study participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive Adebrelimab combined with Famitinib and Irinotecan to assess safety and dose-limiting toxicities during the first 3 months of treatment.
Visits every 3 weeks for medication administration and safety monitoring
Duration - Up to 2 years
Participants are randomized to receive either Adebrelimab combined with Famitinib and Irinotecan or Irinotecan alone until disease progression, intolerable toxicity, death, or up to 2 years.
Treatment visits every 3 weeks for medication administration and assessments
Duration - 90 days
Participants are monitored for adverse events for 90 days after the last dose of medication.
Follow-up visits as needed during 90-day post-treatment period
Trial Site Locations
Total: 1 location
1
Shandong First Medical University Affiliated Cancer Hospital
Jinan, Shandong, China
Actively Recruiting
Research Team
B
Bo Liu, Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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