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PD-1 Antibody + XELOX in 1st Line Serum A-fetoprotein (AFP)-Elevated Gastric or Gastroesophageal Junction Adenocarcinoma

NCT04098796 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-04-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of of anti-PD-1 antibody in combination with chemotherapy as first-line treatment in patients with unresectable, locally advanced recurrent or metastatic serum AFP-elevated gastric and gastroesophageal junction adenocarcinoma.

Conditions

  • Gastric or Gastroesophageal Junction Adenocarcinoma
  • AFP

Interventions

DRUG

Anti-PD-1 antibody

Sintilimab will be administered 200 mg intravenous drip, every 3 weeks. Anti-PD-1 antibody will be administered until the disease progresses or lasts for two years.

DRUG

XELOX

Oxaliplatin 130 mg/m2, intravenous drip, d 1; Capecitabine 1000mg/ kg, twice a day, orally, d1-14; Every 21 days. XELOX 6-8cycles，followed by capecitabine monotherapy, the course of treatment is determined by the investigators according to clinical practice.

Sponsors & Collaborators

  • China Medical University, China

    lead OTHER

Principal Investigators

  • Jingdong Zhang · China Medical University, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04098796 on ClinicalTrials.gov