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A Phase II Study of Carelizumab Combined With Irinotecan and Apatinib of Second-line Treatment for Advanced Gastric Cancer

Primary Purpose

Gastric Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Carelizumab Combined With Irinotecan and Apatinib
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The local advanced stage confirmed by histopathology is unresectable, recurrent or metastatic Adenocarcinoma of stomach and gastroesophageal junction.
  2. After receiving first-line treatment, the disease progressed or intolerable adverse reactions occurred.
  3. At least one measurable lesion or evaluable lesion (according to RECIST 1.1 standard);
  4. Patients agreed to provide blood samples and previously stored tumor tissue samples for tumor microenvironment detection.
  5. Age ≥18 years old and ≤75 years old.
  6. The ECOG score is 0 or 1.
  7. The estimated survival time is ≥3 months.
  8. Within 7 days before entering the group, the laboratory test value met the chemotherapy standard.
  9. 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.
  10. 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:

  1. 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.
  2. 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.
  3. It is known to be allergic to any monoclonal antibody or adjuvant.
  4. Received Chinese patent medicines with anti-tumor indications or drugs with immunoregulatory effects (thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration.
  5. Having undergone major surgery within 4 weeks before the first administration or expecting to undergo surgery during the study treatment.
  6. Receive live attenuated vaccine within 4 weeks before the first administration or during the planned study treatment.
  7. Received transplantation of solid organs or blood system.
  8. 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).
  9. 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.
  10. Known history of primary immunodeficiency disease.
  11. Known history of active tuberculosis. 12 known to have a history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positive).

13. after regular antihypertensive treatment, the blood pressure still cannot fall to the normal range (systolic blood pressure > >140mmHg, diastolic blood pressure > >90mmHg).

14. ≥II grade ii coronary heart disease and arrhythmia (including QTc interval prolongation > >450ms for men and > >470ms for women).

15. Symptomatic congestive heart failure (new york Heart Association Grade II-IV) or symptomatic or poorly controlled arrhythmia.

16. before the first administration, there was toxicity caused by previous anti-tumor treatment that did not recover to grade 0 or grade 1 of the national cancer institute general adverse event terminology version 4.03 (NCI ctcae version 4.03) (excluding alopecia, fatigue and asymptomatic laboratory abnormalities).

17. abnormal coagulation function (INR > 1.5 uln, aptt > 1.5 uln), with bleeding tendency.

18. It is known that symptomatic central nervous system metastasis exists. 19. Diagnosed as other malignant tumors within 5 years before the first administration, excluding basal cell carcinoma of skin, squamous cell carcinoma of skin and carcinoma in situ after radical resection.

20. Active infections requiring treatment or systemic anti-infective drugs used within 7 days before the first administration.

21. acute or chronic active hepatitis b: HBV viral load ≥500 copies /ml 22. Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before the study.

23. It is known that there are mental diseases or drug abuse situations that may affect the compliance with the test requirements.

24. Acute or chronic active hepatitis C: HCV antibody is positive. 25. Pregnant or lactating women. 26. There are medical histories, diseases, treatments or abnormal laboratory results that may interfere with the test results and prevent the subjects from participating in the study, or the researchers think that participating in the study is not in the best interests of the subjects.

Sites / Locations

  • NanFang HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carelizumab Combined With Irinotecan and Apatinib

Arm Description

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

Outcomes

Primary Outcome Measures

Overall Suvival time(OS)
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.

Secondary Outcome Measures

Progress Free Survival time(PFS)
The time from randomization to the first occurrence of disease progression or death from any cause.
objective response rate(ORR)
Refers to the proportion of patients whose tumors have shrunk to a certain amount and kept for a certain time, including CR and PR cases
duration of response (DoR)
It is the curative effect evaluation index of tumor reaction, which refers to the time from the first evaluation of complete remission (CR) or partial remission (PR) to the first evaluation of disease progression (PD) or death from any cause
Disease control rate(DCR)
The proportion of patients whose tumors have shrunk or remained stable for a certain period of time, including cases of complete remission (CR), partial remission (PR) and stable (SD)

Full Information

First Posted
June 12, 2021
Last Updated
June 20, 2021
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04934618
Brief Title
A Phase II Study of Carelizumab Combined With Irinotecan and Apatinib of Second-line Treatment for Advanced Gastric Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2020 (Actual)
Primary Completion Date
May 19, 2023 (Anticipated)
Study Completion Date
May 19, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carelizumab Combined With Irinotecan and Apatinib
Arm Type
Experimental
Arm Description
Second-line treatment of advanced gastric cancer with three-drug regimen(Carelizumab Combined With Irinotecan and Apatinib )
Intervention Type
Drug
Intervention Name(s)
Carelizumab Combined With Irinotecan and Apatinib
Intervention Description
Three-drug regimen was used in second-line treatment of Advanced gastric cancer
Primary Outcome Measure Information:
Title
Overall Suvival time(OS)
Description
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.
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Progress Free Survival time(PFS)
Description
The time from randomization to the first occurrence of disease progression or death from any cause.
Time Frame
Up to 24 months
Title
objective response rate(ORR)
Description
Refers to the proportion of patients whose tumors have shrunk to a certain amount and kept for a certain time, including CR and PR cases
Time Frame
Up to 24 months
Title
duration of response (DoR)
Description
It is the curative effect evaluation index of tumor reaction, which refers to the time from the first evaluation of complete remission (CR) or partial remission (PR) to the first evaluation of disease progression (PD) or death from any cause
Time Frame
Up to 24 months
Title
Disease control rate(DCR)
Description
The proportion of patients whose tumors have shrunk or remained stable for a certain period of time, including cases of complete remission (CR), partial remission (PR) and stable (SD)
Time Frame
Up to 24 months
Other Pre-specified Outcome Measures:
Title
Safety and tolerability
Description
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 1. 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. Known history of active tuberculosis. 12 known to have a history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positive). 13. after regular antihypertensive treatment, the blood pressure still cannot fall to the normal range (systolic blood pressure > >140mmHg, diastolic blood pressure > >90mmHg). 14. ≥II grade ii coronary heart disease and arrhythmia (including QTc interval prolongation > >450ms for men and > >470ms for women). 15. Symptomatic congestive heart failure (new york Heart Association Grade II-IV) or symptomatic or poorly controlled arrhythmia. 16. before the first administration, there was toxicity caused by previous anti-tumor treatment that did not recover to grade 0 or grade 1 of the national cancer institute general adverse event terminology version 4.03 (NCI ctcae version 4.03) (excluding alopecia, fatigue and asymptomatic laboratory abnormalities). 17. abnormal coagulation function (INR > 1.5 uln, aptt > 1.5 uln), with bleeding tendency. 18. It is known that symptomatic central nervous system metastasis exists. 19. Diagnosed as other malignant tumors within 5 years before the first administration, excluding basal cell carcinoma of skin, squamous cell carcinoma of skin and carcinoma in situ after radical resection. 20. Active infections requiring treatment or systemic anti-infective drugs used within 7 days before the first administration. 21. acute or chronic active hepatitis b: HBV viral load ≥500 copies /ml 22. Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before the study. 23. It is known that there are mental diseases or drug abuse situations that may affect the compliance with the test requirements. 24. Acute or chronic active hepatitis C: HCV antibody is positive. 25. Pregnant or lactating women. 26. There are medical histories, diseases, treatments or abnormal laboratory results that may interfere with the test results and prevent the subjects from participating in the study, or the researchers think that participating in the study is not in the best interests of the subjects.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Shi
Phone
020-62787736
Email
nfyyshimin@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chunlin Wang
Phone
020-62787735
Email
wangchunl03@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Shi
Organizational Affiliation
Oncology department of Nanfang hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
NanFang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Shi
Phone
020-62787736
Email
nfyyshimin@163.com
First Name & Middle Initial & Last Name & Degree
Chunlin Wang
Phone
020-62787735
Email
wangchunl03@163.com
First Name & Middle Initial & Last Name & Degree
Min Shi
First Name & Middle Initial & Last Name & Degree
Chunlin Wang

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase II Study of Carelizumab Combined With Irinotecan and Apatinib of Second-line Treatment for Advanced Gastric Cancer

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