Actively Recruiting
Adebrelimab Plus Apatinib Combined With SOX Regimen as Conversion Therapy for Gastric Cancer
Led by Beijing Friendship Hospital · Updated on 2026-04-22
49
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single-center, single-arm, open phase II clinical study. Forty-nine participants with pathologically or cytologically confirmed gastric cancer or gastroesophageal junction cancer are scheduled to be enrolled in this study. All participants will be treated with 2 to 8 cycles of adebrelimab, apatinib, oxaliplatin, and tigio before surgery. Participants will evaluate the treatment effect after every 2 cycles of medication. By the investigator assessment as an operable subject, apatinib was discontinued for one cycle. The adjuvant treatment will be determined by the investigators based on the participants' postoperative pathology results. Participants requiring adjuvant therapy, with a postoperative interval of at least 4 weeks, but not more than 10 weeks. When the resection standard isn't met for 8 cycles of treatment, the treatment is switched to a maintenance phase, which the subject treatment regimen is determined by the investigator. During the treatment period, participants will receive the study drugs on Day 1 of each 21-day cycle until evidence of disease progression or unacceptable toxicity.
CONDITIONS
Official Title
Adebrelimab Plus Apatinib Combined With SOX Regimen as Conversion Therapy for Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at enrollment with life expectancy of at least 3 months
- Confirmed diagnosis of gastric cancer or gastroesophageal junction cancer, mainly adenocarcinoma
- Unresectable locally advanced gastric or gastroesophageal junction adenocarcinoma (Stage III or IV) confirmed by imaging
- Disease eligible for conversion therapy as judged by the investigator
- No previous anti-tumor treatments such as chemotherapy, radiotherapy, targeted therapy, or immunotherapy
- ECOG performance status of 0 to 2
- Adequate blood counts and organ function within 14 days before enrollment
- Negative pregnancy test for women of childbearing potential and agreement to use contraception during the study and for 12 weeks after
- Male participants must be surgically sterile or agree to use contraception during the study and for 12 weeks after
- Willing and able to provide informed consent and comply with study requirements
You will not qualify if you...
- HER2-positive gastric or gastroesophageal junction adenocarcinoma
- Conditions impairing oral drug absorption such as inability to swallow, persistent nausea, vomiting, chronic diarrhea, or intestinal blockage
- Allergies to study drugs or their ingredients
- History of severe allergic reactions to monoclonal antibodies
- Active autoimmune diseases needing systemic treatment
- Immunodeficiency disorders
- Use of systemic immunosuppressants within 14 days before starting treatment
- Receipt of live vaccines within 4 weeks before or planned during the study
- Severe infections within 4 weeks prior to treatment
- History of organ or stem cell transplantation
- Lung diseases like interstitial lung disease or severe lung impairment
- Uncontrolled high blood pressure or significant heart disease
- High risk of severe bleeding
- Peripheral neuropathy worse than Grade 2
- Participation in another interventional trial recently
- Any other condition making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
Research Team
W
Wei Deng, MD
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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