PD-1 Antibody + Apatinib Mesylate in 2+ Line Serum AFP-elevated Gastric Adenocarcinoma

Sponsor
China Medical University, China
Study ID
NCT04006821
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • PD-1 antibody — DRUG
    Camrelizumab will be administered 200mg iv every 2 weeks until disease progression or lasts for two years.
  • Apatinib mesylate — DRUG
    Apatinib mesylate will be administered 250mg or 500mg (according to the patient's tolerance), qd, oral, until disease progression.

Study Details

The purpose of this study is to evaluate the efficacy and safety of PD-1 antibody combined with apatinib mesylate in patients with unresectable, local advanced recurrent or metastatic serum AFP-elevated gastric adenocarcinoma, who have at least received first-line antitumor therapy or whose standard treatment is intolerable.

Key Dates

Start date
Jul 25, 2019
Status verified
Sep 2021
Primary completion
Aug 1, 2022
Completion
Aug 1, 2022

Study Design

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

Arms

  • Experimental: PD-1 antibody + Apatinib mesylate
    Every patient will receive PD-1 antibody 200mg iv every 2 weeks and apatinib 250mg or 500mg (according to the patient's tolerance) orally every day. PD-1 antibody will be administered until disease progression or lasts for two years. Apatinib mesylate will be administered until disease progression.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: 2 years ]

Central Contacts

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