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Sintilimab and Nab-paclitaxel in Second-line Treatment of Advanced Gastric or Gastro-oesophageal Junction Adenocarcinoma

NCT04140318 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-03-11

No results posted yet for this study

Summary

To evaluate the efficacy and safety of Sintilimab (PD-1 inhibitor) and nab-paclitaxel in second line treatment of advanced gastric and gastro-esophageal junction adenocarcinoma. This is a prospective, multi-centers, single arm phase II trial with primary objective overall response rate and second objective of safety and other efficacy endpoints.

Conditions

  • Advanced Gastric and Gastro-esophageal Junction Adenocarcinoma

Interventions

DRUG

sintilimab

Sintilimab 200mg, iv, 30-60min, q3w;

DRUG

nab-paclitaxel

Nab-paclitaxel: 125 mg/m2 iv d1、d8, q3w

Sponsors & Collaborators

  • Chinese PLA General Hospital

    collaborator OTHER

  • Beijing Friendship Hospital

    collaborator OTHER

  • Beijing Hospital

    collaborator OTHER_GOV

  • Chinese Academy of Medical Sciences

    lead OTHER

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
2019-11-15
Primary Completion
2022-08-30
Completion
2023-02-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04140318 on ClinicalTrials.gov