Actively Recruiting
Phase II Study of PD-1 Antibody Carilizumab Combined with Apatinib for Unresectable Stage III and IV dMMR Gastric Cancer
Led by Peking University Third Hospital · Updated on 2025-01-24
20
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining the PD-1 antibody Carilizumab with Apatinib as a conversion therapy for patients with unresectable stage III and IV dMMR gastric cancer who have not received prior anti-tumor treatment. This phase II, open-label study is conducted at a single center and aims to enroll 20 patients to measure the 1-year progression-free survival rate. The focus is on patients whose cancer may respond to this combined treatment to potentially make surgery possible. Participants receive Carilizumab and Apatinib every 21 days. After every two treatment cycles, doctors assess whether surgery can be performed. If surgery is feasible, Apatinib is stopped for one cycle and an additional dose of Carilizumab is given before surgery, which occurs within 3 to 6 weeks after the last dose. Both patients who undergo surgery and those who do not continue the combined treatment until disease progression, recurrence, or death, for up to two years. During the study, participants have regular evaluations including imaging to monitor disease status. After treatment ends, there are safety visits and survival follow-ups every 90 days to track health and any further anti-tumor treatments. This ongoing monitoring helps researchers understand the treatment's effects and patient outcomes over time.
CONDITIONS
Official Title
PD-1 Antibody Carilizumab Combined with Apatinib for Unresectable Stage III and IV DMMR Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Histologically confirmed unresectable stage III or IV dMMR gastric adenocarcinoma or gastroesophageal junction adenocarcinoma
- Gastric cancer with potential for conversion therapy, including single organ metastasis, lymph node metastasis, localized peritoneal metastasis, or invasion of surrounding organs
- No prior surgery, radiation therapy, or immunotherapy for gastric cancer or metastases
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- Normal main organ functions without severe abnormalities
- Normal blood clotting function and no active bleeding or thrombotic diseases
- At least 2 weeks since last use of traditional Chinese medicine or immunomodulators with anti-tumor drugs
- Use of medically approved contraception during and for 180 days after treatment for females of childbearing age and males with partners of childbearing age
- Negative serum HCG test within 72 hours before enrollment for females of childbearing age who are not surgically sterilized
- Willingness to participate and signed informed consent form
You will not qualify if you...
- Diagnosis of other malignant tumors within 5 years except certain treated cancers
- Active or history of autoimmune diseases requiring medical intervention
- Congenital or acquired immune deficiency including HIV or active hepatitis B or C infections
- Use of immunosuppressive drugs within 14 days before starting treatment (except low-dose corticosteroids)
- Vaccination with live attenuated vaccine within 4 weeks before or planned during the study
- Uncontrolled hypertension despite medication
- Unstable heart conditions, including recent heart attack or severe heart failure
- Lung diseases affecting pulmonary function or suspected drug-related lung toxicity
- Active pulmonary tuberculosis
- Severe infections requiring intravenous antibiotics within 4 weeks before treatment
- History of allogeneic organ or stem cell transplantation
- Known allergies to study drug components
- Other severe, acute, or chronic illnesses increasing risks or interfering with study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University third hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yanhong Yao
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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