Study of Camrelizumab (SHR-1210) and Apatinb Based Therapies for Alpha-fetoprotein (AFP)-Producing Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Sponsor
Peking University
Study ID
NCT04609176
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab plus Apatinib and SOX — DRUG
    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.
  • Camrelizumab plus Apatinib — DRUG
    Camrelizumab 200mg, day1; Apatinib 250mg qd p.o. 3 weeks for one cycle.

Study Details

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).

Key Dates

Start date
Nov 18, 2020
Status verified
Apr 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2024

Study Design

Enrollment
64 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab+Apatinib+SOX
    Participants who have not received any previous therapy for their disease will receive Camrelizumab and Apatinib in combination with Oxaliplatin and S-1. 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.
  • Experimental: Camrelizumab+Apatinib
    Participants who have received at least one prior therapy for their advanced disease will receive Camrelizumab and Apatinib. Camrelizumab 200mg, day1; Apatinib 250mg qd p.o. 3 weeks for one cycle.

Primary Outcome Measure

Objective Response Rate (ORR) According to RECIST 1.1 based on investigator assessment [ Time Frame: Up to approximately 24 months ]

Central Contacts

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