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Efficacy and Safety of Camrelizumab for Injection, Apatinib Mesylate and Tegio for First-line Refractory Patients With Advanced Gastric Cancer

Primary Purpose

Gastric Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Camrelizumab for injection, apatinib mesylate and tegio

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. Aged 18-75;
2. ECOG score 0-2;
3. Pathologically diagnosed late-stage adenocarcinoma of stomach or gastroesophageal junction, with extra-gastric measurable lesions (spiral CT scan≥10 mm, meeting RECIST 1.1 criteria);
4. Patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma that are refractory to first-line chemotherapy;
5. Patients who received no previous treatment with apatinib or other VEGFR inhibitors, e.g. sorafenib and sunitinib;
6. Normal blood routine examination: Neutrophil count ≥ 1.5 × 109 / L; Hemoglobin ≥ 80 g / L; Platelet count ≥ 100 × 109 / L; Total bilirubin ≤ 1.5 × ULN; ALT, AST≤2.5×ULN；
7. Without severe dysfunction of heart, lung, liver or kidney, without jaundice and digestive tract obstruction, and without acute infection.

Exclusion Criteria:

1. KPS < 60, or estimated survival < 3 months;
2. Patients with cardiovascular and cerebrovascular events within half a year; patients with uncontrollable hypertension (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg), coronary heart disease above grade I, arrhythmia (including QTc interval prolongation > 450 ms in men, 470 MS in women) and grade I cardiac dysfunction; patients positive of urine albumin;
3. Patients with definite tendency of gastrointestinal bleeding, local active ulcer focus, and occult blood in stool (+ +); patients with history of black stool and hematemesis within 2 months;
4. Abnormal coagulation (INR > 1.5, APTT > 1.5 ULN), with bleeding tendency;
5. Patients with factors that can affect the absorption of oral-intake drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.);
6. Patients with nervous and mental diseases or with severe infection;
7. Pregnant or lactating women or those who have fertility requirements during the study period.

Sites / Locations

Beijing Friendship Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Camrelizumab+Apatinib Mesylate+Tegio

Arm Description

Outcomes

Primary Outcome Measures

DFS

disease free survival

overall survival

Secondary Outcome Measures

Full Information

NCT ID

NCT04345783

First Posted

April 12, 2020

Last Updated

April 12, 2020

Sponsor

Beijing Friendship Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04345783

Brief Title

Efficacy and Safety of Camrelizumab for Injection, Apatinib Mesylate and Tegio for First-line Refractory Patients With Advanced Gastric Cancer

Official Title

A Study on the Efficacy and Safety of Camrelizumab for Injection, Apatinib Mesylate and Tegio for First-line Refractory Patients With Advanced Gastric Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Friendship Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This is a prospective, single-center, single-arm, open-label clinical study, aiming at evaluating the efficacy and safety of camrelizumab for injection, apatinib mesylate and tegio for first-line refractory patients with advanced gastric cancer.

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

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Camrelizumab+Apatinib Mesylate+Tegio

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Camrelizumab for injection, apatinib mesylate and tegio

Intervention Description

Camrelizumab for injection: fixed dose of 200 mg, ivgtt for 30 minutes, given on D1, repeat for every 3 weeks; Apatinib mesylate: 250 mg, p.o, qd; Tegio capsule: p.o., bid, D1-14, repeat for every 21 days.

Primary Outcome Measure Information:

Title

DFS

Description

disease free survival

Time Frame

3 years

Title

Description

overall survival

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1. Aged 18-75; 2. ECOG score 0-2; 3. Pathologically diagnosed late-stage adenocarcinoma of stomach or gastroesophageal junction, with extra-gastric measurable lesions (spiral CT scan≥10 mm, meeting RECIST 1.1 criteria); 4. Patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma that are refractory to first-line chemotherapy; 5. Patients who received no previous treatment with apatinib or other VEGFR inhibitors, e.g. sorafenib and sunitinib; 6. Normal blood routine examination: Neutrophil count ≥ 1.5 × 109 / L; Hemoglobin ≥ 80 g / L; Platelet count ≥ 100 × 109 / L; Total bilirubin ≤ 1.5 × ULN; ALT, AST≤2.5×ULN； 7. Without severe dysfunction of heart, lung, liver or kidney, without jaundice and digestive tract obstruction, and without acute infection. Exclusion Criteria: 1. KPS < 60, or estimated survival < 3 months; 2. Patients with cardiovascular and cerebrovascular events within half a year; patients with uncontrollable hypertension (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg), coronary heart disease above grade I, arrhythmia (including QTc interval prolongation > 450 ms in men, 470 MS in women) and grade I cardiac dysfunction; patients positive of urine albumin; 3. Patients with definite tendency of gastrointestinal bleeding, local active ulcer focus, and occult blood in stool (+ +); patients with history of black stool and hematemesis within 2 months; 4. Abnormal coagulation (INR > 1.5, APTT > 1.5 ULN), with bleeding tendency; 5. Patients with factors that can affect the absorption of oral-intake drugs (such as inability to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.); 6. Patients with nervous and mental diseases or with severe infection; 7. Pregnant or lactating women or those who have fertility requirements during the study period.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Deng, M.D.

Organizational Affiliation

Beijing Friendship Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Beijing Friendship Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100050

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Time Frame

from 2022.12 on

Citations:

PubMed Identifier

35304622

Citation

Jing C, Wang J, Zhu M, Bai Z, Zhao B, Zhang J, Yin J, Yang X, Liu Z, Zhang Z, Deng W. Camrelizumab combined with apatinib and S-1 as second-line treatment for patients with advanced gastric or gastroesophageal junction adenocarcinoma: a phase 2, single-arm, prospective study. Cancer Immunol Immunother. 2022 Nov;71(11):2597-2608. doi: 10.1007/s00262-022-03174-9. Epub 2022 Mar 18.

Results Reference

derived

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Efficacy and Safety of Camrelizumab for Injection, Apatinib Mesylate and Tegio for First-line Refractory Patients With Advanced Gastric Cancer

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