Apatinib Plus Camrelizumab Combined With Docetaxel and S1 in First-line Treatment for Metastatic Gastric Cancer

Sponsor
Zhou Fuxiang
Study ID
NCT04781686
Phase
PHASE2
Status
Unknown

Conditions

  • Metastatic Gastric Adenocarcinoma
  • Metastatic Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    Camrelizumab (200mg) will be given i.v. on day 1 of each 3-week cycle
  • Apatinib Mesylate — DRUG
    Apatinib (250mg) will be administered orally once a day .
  • S1 — DRUG
    S1 (BSA\<1.25 40mg, BSA \>=1.25-\<1.5 50mg, BSA \>=1.5 60mg) will be administered orally twice daily on days 1-7 of each 3-week cycle
  • Docetaxel injection — DRUG
    Docetaxel (75mg/m2 IV.drop) will be administered on day 1 of each 3-week cycle, for six cycles.

Study Details

The purpose of this study is to evaluate the efficacy and safety of Apatinib plus Camrelizumab combined with docetaxel and S-1 as the first-line treatment of metastatic adenocarcinoma of gastric and gastroesophageal junction.

Key Dates

Start date
May 14, 2021
Status verified
May 2021
Primary completion
Aug 31, 2024
Completion
Aug 31, 2025

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: First-line treatment
    First-line treatment: Apatinib plus Camrelizumab combined with Docetaxel and S1 for six cycles. Maintenance treatment: Apatinib and Camrelizumab

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: 36 months ]

Central Contacts

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