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

NCT04934618 | Unknown Phase 2

• 1 other identifier: NFEC-2020-024
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 24 months

Secondary Outcomes (4)

• Progress Free Survival time（PFS）

  Up to 24 months

• objective response rate（ORR）

  Up to 24 months

• duration of response （DoR）

  Up to 24 months

• Disease control rate（DCR）

  Up to 24 months

Other Outcomes (1)

• Safety and tolerability

  Up to 24 months

Study Arms (1)

Carelizumab Combined With Irinotecan and Apatinib

EXPERIMENTAL

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

Drug: Carelizumab Combined With Irinotecan and Apatinib

Interventions

Carelizumab Combined With Irinotecan and Apatinib DRUG

Three-drug regimen was used in second-line treatment of Advanced gastric cancer

Carelizumab Combined With Irinotecan and Apatinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• \. after regular antihypertensive treatment, the blood pressure still cannot fall to the normal range (systolic blood pressure \> \>140mmHg, diastolic blood pressure \> \>90mmHg).
• \. ≥II grade ii coronary heart disease and arrhythmia (including QTc interval prolongation \> \>450ms for men and \> \>470ms for women).
• \. Symptomatic congestive heart failure (new york Heart Association Grade II-IV) or symptomatic or poorly controlled arrhythmia.
• \. 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).

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

NanFang Hospital

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Irinotecan; apatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Min Shi

  Oncology department of Nanfang hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Shi

CONTACT

020-62787736; nfyyshimin@163.com

Chunlin Wang

CONTACT

020-62787735; wangchunl03@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director of Oncology Department

Study Record Dates

• First Submitted: June 12, 2021
• First Posted: June 22, 2021
• Study Start: May 19, 2020
• Primary Completion: May 19, 2023
• Study Completion: May 19, 2025
• Last Updated: June 22, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)