Actively Recruiting
Adebrelimab Combined With Famitinib and Irinotecan in Advanced Gastric Cancer After Failure of First-Line Therapy
Led by Shandong Tumor Hospital · Updated on 2025-12-30
66
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study employs a randomized, controlled, exploratory clinical trial design, with a planned enrollment of 66 patients who have previously failed systemic chemotherapy for recurrent/metastatic gastric cancer,
CONDITIONS
Official 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 diagnosed with advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma 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 not previously treated locally or confirmed progression in irradiated lesions according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Expected survival of at least 12 weeks
- Adequate organ function as shown by blood counts, liver function tests, and renal function meeting study standards
- Use of medically approved contraception during treatment and for 6 months after last treatment for females of childbearing potential and males with partners who are fertile women
- Voluntary informed consent, good compliance, and willingness to follow study procedures
You will not qualify if you...
- History of gastrointestinal perforation or fistula within 6 months before starting treatment
- Presence of uncontrollable pleural, pericardial, or peritoneal effusions requiring repeated drainage
- History of allergies to any Adebrelimab components
- Receipt of other investigational drugs within 4 weeks or drugs with longer half-life
- Participation in other clinical studies except observational or follow-up studies
- Anti-tumor therapy within 2 weeks before starting study drug
- Use of corticosteroids above 10 mg prednisone equivalent daily within 2 weeks before treatment, except for routine chemotherapy pretreatment
- Receipt of anti-tumor or live vaccines within 4 weeks before treatment
- Major surgery or severe trauma within 4 weeks before treatment
- Previous treatment with paclitaxel drugs
- Unresolved toxicity from prior cancer treatments above CTCAE grade 1 except hair loss
- Active central nervous system metastases
- Active or history of autoimmune diseases requiring intervention, excluding stable conditions
- Immune deficiency disorders or organ transplantation history
- Uncontrolled cardiovascular disease or symptoms
- Severe infection within 4 weeks before treatment or active pulmonary inflammation
- History of interstitial lung disease excluding radiation or non-infectious pneumonias
- Active or recent pulmonary tuberculosis infection
- Other malignancies within 5 years except low-risk skin or cervical cancers
- Pregnant or breastfeeding women
- Other serious illnesses or conditions that could affect safety or study participation as assessed by the investigator
AI-Screening
AI-Powered Screening
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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.
CONTACT
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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