A Single-arm, Multicenter, Open-labeled, Phase II Study on the Efficacy and Safety of Carelizumab Combined With Irinotecan and Apatinib in the Second-line Treatment of Locally Advanced Unresectable, Recurrent or Metastatic Adenocarcinoma of Stomach and Gastroesophageal Junction

Nanfang Hospital, Southern Medical University1 site in 1 country85 target enrollmentMay 19, 2020

ConditionsGastric Cancer

InterventionsCarelizumab Combined With Irinotecan and Apatinib

DrugsCarelizumab Combined With Irinotecan and Apatinib

Overview

Phase: Phase 2
Intervention: Carelizumab Combined With Irinotecan and Apatinib
Conditions: Gastric Cancer
Sponsor: Nanfang Hospital, Southern Medical University
Enrollment: 85
Locations: 1
Primary Endpoint: Overall Suvival time（OS）
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study was to evaluate the overall survival time (OS), objective remission rate（ORR）, progression-free survival time（PFS）, disease control rate（DCR）of Carelizumab combined with irinotecan and apatinib for the second-line treatment of locally advanced unresectable, recurrent or metastatic adenocarcinoma of stomach and gastroesophageal junction. At the same time, the safety and tolerance of the scheme were preliminarily evaluated.

Registry

clinicaltrials.gov

Start Date

May 19, 2020

End Date

May 19, 2025

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Nanfang Hospital, Southern Medical University

Responsible Party

Principal Investigator

Shimin

Vice director of Oncology Department

Nanfang Hospital, Southern Medical University

Eligibility Criteria

Inclusion Criteria

•The local advanced stage confirmed by histopathology is unresectable, recurrent or metastatic Adenocarcinoma of stomach and gastroesophageal junction.
•After receiving first-line treatment, the disease progressed or intolerable adverse reactions occurred.
•At least one measurable lesion or evaluable lesion (according to RECIST 1.1 standard);
•Patients agreed to provide blood samples and previously stored tumor tissue samples for tumor microenvironment detection.
•Age ≥18 years old and ≤75 years old.
•The ECOG score is 0 or
•The estimated survival time is ≥3 months.
•Within 7 days before entering the group, the laboratory test value met the chemotherapy standard.
•Within 28 days before enrollment, women of childbearing age must confirm that the serum pregnancy test is negative and agree to adopt effective contraceptive measures during the study drug use and within 6 months after the last administration.
•Patients voluntarily joined the study, signed informed consent, and were able to comply with the visit and related procedures stipulated in the plan.

Exclusion Criteria

•Participate in other intervention clinical studies at the same time (unless participating in observation studies or being in the follow-up stage of intervention studies), and have received second-line treatment.
•have received antibody therapy of PD-1, PD-L1, PD-L2, CTLA4, CD137 or any other antibody or drug therapy with t cell co-stimulation or immune checkpoint pathway as specific target.
•It is known to be allergic to any monoclonal antibody or adjuvant.
•Received Chinese patent medicines with anti-tumor indications or drugs with immunoregulatory effects (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration.
•Having undergone major surgery within 4 weeks before the first administration or expecting to undergo surgery during the study treatment.
•Receive live attenuated vaccine within 4 weeks before the first administration or during the planned study treatment.
•Received transplantation of solid organs or blood system.
•Active, known or suspected autoimmune diseases or related medical history in the past 2 years (vitiligo, psoriasis, alopecia or Graves' disease that does not require systematic treatment in the past 2 years, hypothyroidism that only requires thyroid hormone replacement therapy, and type I diabetes patients who only need insulin replacement therapy can enter Group).
•Immunosuppressive drugs have been used within 4 weeks before the first administration, excluding local glucocorticoid by nasal spray, inhalation or other routes or systemic glucocorticoid with physiological dose (i.e., prednisone or other glucocorticoid with equivalent dose not exceeding 10mg/ day), or hormone used due to allergy.
•Known history of primary immunodeficiency disease.

Arms & Interventions

Carelizumab Combined With Irinotecan and Apatinib

Second-line treatment of advanced gastric cancer with three-drug regimen（Carelizumab Combined With Irinotecan and Apatinib ）

Intervention: Carelizumab Combined With Irinotecan and Apatinib

Outcomes

Primary Outcomes

Overall Suvival time（OS）

Time Frame: Up to 24 months

The time from randomization to death due to any reason. For those who have lost follow-up before death, the last follow-up time is usually calculated as the time of death.