Camrelizumab Combined With Chemotherapy in First-line Treatment of HER2-positive Gastric Cancer

September 27, 2021 updated by: Caigang Liu, Shengjing Hospital

A Prospective, Single-arm, Phase II Study of Camrelizumab Combined With Pyrotinib Maleate, Nab-paclitaxel and Tegafur Chemotherapy in First-line Treatment of HER2-positive Gastric Cancer

According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety, or affect the patient's completion of the study (such as uncontrolled hypertension, diabetes, thyroid disease, etc.);

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shenyang, China
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- rious hepatic and renal impairment, organ function must meet the following requirements: ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L; Hb ≥ 90g/L; TBIL ≤ 1.5 × ULN; ALT and AST ≤1.5 × ULN, ALP ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN BUN and Cr ≤ 1 × ULN and cre

Exclusion Criteria:

  • rious hepatic and renal impairment, organ function must meet the following requirements: ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L; Hb ≥ 90g/L; TBIL ≤ 1.5 × ULN; ALT and AST ≤1.5 × ULN, ALP ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN BUN and Cr ≤ 1 × ULN and cre

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur
Camrelizumab Q3W d1 Pyrotinib d1-21 Nab-paclitaxel Q3W d1 Tegafur d1-14
Drug: Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur
Camrelizumab was given in the first day of each cycle,Nab-paclitaxel was given in the first day of each cycle, Pyrotinib was given everyday of each cycle, Tegafur given in the day 1-14 of each cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR (Objective control rate)
Time Frame: up to 12 months
The rate of CR and PR, determined using RECIST v1.1 criteria
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DCR (Disease control rate)
Time Frame: up to 12 months
The rate of CR, PR plus SD
up to 12 months
PFS (Progression-Free survival)
Time Frame: up to 12 months
From the date Into this study (signed ICF) to tumor progression or death for any
up to 12 months
OS(Overall survival)
Time Frame: up to approximately 24 months
Baseline until death from any cause
up to approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shengjing Hospital

Investigators

  • Study Chair: Caigang Liu, doctor, Shengjing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2021

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

March 30, 2024

Study Registration Dates

First Submitted

September 27, 2021

First Submitted That Met QC Criteria

September 27, 2021

First Posted (Actual)

October 7, 2021

Study Record Updates

Last Update Posted (Actual)

October 7, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shengjing-LCG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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