Efficacy and safety of Thymosin alpha 1 combined with anti-PD-1 and Apatinib in advanced gastric cancer patients failed to second line treatment
Phase 1
- Conditions
- Advanced Gastric Cancer
- Registration Number
- ITMCTR1900002540
- Lead Sponsor
- Shanghai Dongfang Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1. Male or female, aged above 18 years;
2. ECOG 0-1;
3. Pathological diagonosed of advanced gastric cancer or gastric esophageal junction adenocarcinoma;
4. According to iRECIST criteria, there is at least one measurable lesion;
5. Atlease 2 weeks apart from local palliative radiotherapy to randomization;
6. Advanced gastric cancer failed to 2 or more lines treatment.
Exclusion Criteria
1. Known allergic or untolerant to Apatinib,PD-1 antibody or Thymosin alpha 1;
2. Uncontrolled variety syndromes;
3. With unsolved adverse event related with PD-1 therapy.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ORR;AE incident rate;PFS;
- Secondary Outcome Measures
Name Time Method DCR;OS;