Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer

December 20, 2022 updated by: Ji Zhu, Zhejiang Cancer Hospital

A Randomized, Controlled, Multicenter Phase II Study of Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer

This study is a multicenter, open, and randomized clinical phase II exploratory study. The "pick the winner" study design is used to determine and select which chemotherapy drug (irinotecan vs. albumin plus paclitaxel) is more effective in the second-line treatment of advanced gastric cancer, and it is more hopeful to carry out the follow-up phase III study in the second-line treatment of advanced gastric cancer (karelizumab+chemotherapy vs. chemotherapy). The study plans to include 184 patients with advanced gastric cancer who have received first-line platinum+fluorouracil progression, randomly use albumin paclitaxel+carrelizumab or irinotecan+carrelizumab second-line therapy, and observe the objective effective rate (ORR), total survival time (OS), progression free survival time (PFS), treatment related adverse reactions, quality of life and other clinical indicators after receiving the above treatment, Then determine the second line scheme which is more advantageous.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

184

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

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

15 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 18-75
  • ECOG score: 0 or 1
  • Unresectable advanced or recurrent gastric cancer/gastroesophageal junction cancer
  • histologically proven adenocarcinoma
  • Received chemotherapy based on platinum and fluorouracil within 12 months
  • Patients not previously treated with paclitaxel or irinotecan
  • Liver function: total bilirubin, ALT and AST<1.5 × ULN (Normal Value upper limit)
  • Renal function: Cr<1.5 × ULN and creatinine clearance ≥ 40 ml/min
  • Echocardiography or radionuclide cardiac function test, LVEF ≥ 50%
  • Expected survival ≥ 3 months
  • Sign the informed consent form

Exclusion Criteria:

  • Patients who have received irinotecan or paclitaxel chemotherapy in the past
  • ECOG PS score:>2
  • Advanced gastric cancer patients with extensive and severe peritoneal metastasis
  • Patients with severe liver and kidney insufficiency or cardiac insufficiency
  • HIV positive, active hepatitis B or C, active pulmonary tuberculosis
  • Patients with active autoimmune diseases, including lupus erythematosus, rheumatoid arthritis, rheumatoid arthritis, etc
  • Patients known to be allergic to any of the study drugs
  • Pregnant or lactating female patients

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A: Camrelizumab+Albumin-bound paclitaxel
Camrelizumab 200mg d1, one cycle every 14 days on the first day; albumin binding paclitaxel: 100 mg/m2, one cycle every 28 days on the first, eighth and fifteenth days
Drug: Camrelizumab
200mg d1, the first day, every 14 days as a cycle
Other Names:
  • Camrel
Drug: Albumin-Bound Paclitaxel
100 mg/m2, the 1st, 8th and 15th days, every 28 days as a cycle
Other Names:
  • ABP
Experimental: B: Camrelizumab+Irinotecan
Camrelizumab 200mg d1, the first day, every 14 days as a cycle Irinotecan: 180 mg/m2, the first day, every 14 days as a cycle
Drug: Camrelizumab
200mg d1, the first day, every 14 days as a cycle
Other Names:
  • Camrel
Drug: Irinotecan
180 mg/m2, the first day, every 14 days as a cycle
Other Names:
  • Iri

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: up to 12 weeks
CR+PR
up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From date of randomization until the date of date of death from any cause, assessed up to 24 months
Time from random start of treatment to death from any cause
From date of randomization until the date of date of death from any cause, assessed up to 24 months
Progression-free Survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Time from random start of treatment to death or tumor progression due to any reason
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Treatment related adverse reactions
Time Frame: 24 months
Evaluation according to CTC 4.0
24 months
Quality of life assessment
Time Frame: 24 months
according to EORTC C30
24 months

Collaborators and Investigators

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

Sponsor

Zhejiang Cancer Hospital

Investigators

  • Principal Investigator: Ji Zhu, Zhejiang Cancer 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 (Anticipated)

December 1, 2022

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

November 1, 2025

Study Registration Dates

First Submitted

November 28, 2022

First Submitted That Met QC Criteria

December 20, 2022

First Posted (Actual)

January 3, 2023

Study Record Updates

Last Update Posted (Actual)

January 3, 2023

Last Update Submitted That Met QC Criteria

December 20, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARTOnG-2101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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