Trials / Unknown
UnknownNCT04609176
Study of Camrelizumab (SHR-1210) and Apatinb Based Therapies for Alpha-fetoprotein (AFP)-Producing Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
A Prospective, Non-randomized, Multicenter, Phase II Study of Camrelizumab (SHR-1210) and Apatinb Based Therapies for Unresectable Recurrent or Metastatic Alpha-fetoprotein (AFP)-Producing Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- Sponsor
- Peking University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a study of Camrelizumab (SHR-1210) and Apatinb for unresectable Recurrent or metastatic alpha-fetoprotein (AFP)-producing gastric cancer or Gastroesophageal Junction Adenocarcinoma. Camrelizumab combined with Apatinib and standard chemotherapy will be given to treatment-naïve participants; Camrelizumab combined with Apatinib will also be evaluated in participants who have had ≥ 1 line of previous treatment. The primary endpoint is the Overall Response Rate (ORR).
Detailed description
This study will have 2 cohorts. In Cohort 1, participants who have not received any previous therapy for their disease will receive Camrelizumab and Apatinib in combination with Oxaliplatin and S-1. In Cohort 2, participants who have received at least one prior therapy for their advanced disease will receive Camrelizumab and Apatinib. A Simon two-stage phase II design was used for the sample size Calculation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Camrelizumab plus Apatinib and SOX | Camrelizumab 200mg, day1; Apatinib 250mg qd p.o.;Oxaliplatin 130 mg/m2 day1; S-1 40-60 mg (calculated according to the body surface area) bid day1-14. 3 weeks for one cycle. |
| DRUG | Camrelizumab plus Apatinib | Camrelizumab 200mg, day1; Apatinib 250mg qd p.o. 3 weeks for one cycle. |
Timeline
- Start date
- 2020-11-18
- Primary completion
- 2023-12-31
- Completion
- 2024-12-31
- First posted
- 2020-10-30
- Last updated
- 2023-04-21
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04609176. Inclusion in this directory is not an endorsement.