Actively Recruiting
Capeox Regimen Combined With Sintilimab and Bevacizumab for Gastric Cancer
Led by West China Hospital · Updated on 2023-05-16
57
Participants Needed
1
Research Sites
190 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The median survival time of first-line chemotherapy for advanced gastric cancer is about one year, and the treatment is still facing the bottleneck. This is a one-arm, open and prospective phase II clinical study. Recruit patients who have been diagnosed with advanced or metastatic adenocarcinoma of the stomach and gastroesophageal junction and have not received systematic treatment.
CONDITIONS
Official Title
Capeox Regimen Combined With Sintilimab and Bevacizumab for Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or cytological diagnosis of adenocarcinoma of stomach or gastroesophageal junction
- Unresectable recurrent or metastatic disease confirmed by imaging or surgery
- Expected survival of more than 3 months
- Age between 18 and 70 years, any gender
- No prior systemic treatment for advanced or metastatic disease; prior adjuvant/neoadjuvant therapy completed at least 6 months before with no progression
- Palliative radiotherapy completed at least 2 weeks before treatment
- Eastern Cooperative Oncology Group (ECoG) performance status 0-1
- At least one measurable lesion per RECIST 1.1 criteria
- Available pathological tissue samples within 6 months for testing
- Normal organ function including blood counts, liver and kidney tests, and coagulation within specified limits
- Acute toxicity from prior treatments resolved to grade 0-1
- Negative pregnancy test for women of childbearing potential and agreement to use effective contraception
- Consent to follow study visits, treatments, and tests
You will not qualify if you...
- Known HER2 positive status
- Gastric cancer types other than adenocarcinoma, or mixed tissue types
- Uncontrolled or symptomatic active central nervous system metastases
- Uncontrolled pleural effusion or ascites, symptomatic pericardial effusion
- Weight loss greater than 20% within 2 months before enrollment
- Major surgery within 28 days before enrollment (excluding biopsy or catheter placement)
- Recent immunosuppressive drug use within 7 days before enrollment (excluding nasal/inhaled corticosteroids or physiological doses)
- Live attenuated vaccine within 28 days before enrollment or within 60 days after treatment
- Antineoplastic therapy within 28 days before enrollment
- Other malignancies diagnosed within 3 years except certain localized cancers
- Active autoimmune disease requiring systemic therapy
- Prior treatment with anti-PD-1/PD-L1 or anti-CTLA-4 antibodies
- Significant bleeding or thrombotic events within specified periods
- Major vascular disease within 6 months before study
- Severe wounds, ulcers, or untreated fractures
- Peripheral neuropathy above grade 1
- Interstitial lung disease or uncontrolled systemic diseases
- Known allergy to study drugs or monoclonal antibodies
- HIV infection or AIDS
- Untreated hepatitis B or C infection
- Recent serious cardiovascular events or poorly controlled hypertension
- Recent prolonged antibiotic use or fever of unknown origin
- History of organ transplantation
- Participation in another drug trial within 4 weeks before enrollment
- History of substance abuse
- Other severe physical or mental conditions increasing study risk or interfering with results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Liu Ming
Chengdu, China
Actively Recruiting
Research Team
L
Liu Ming, Professor
CONTACT
D
Dai Ruihong, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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