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Camrelizumab Combined With Apatinib in the Treatment of Patients With Advanced Gastric Cancer and Colorectal Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE1/PHASE2

Camrelizumab Combined With Apatinib in the Treatment of Patients With Advanced Gastric Cancer and Colorectal Cancer

Camrelizumab Combined With Apatinib in the Treatment of Patients With Advanced Gastric Cancer and Colorectal Cancer：One-arm Exploratory Clinical Trial

NCT04067986•Zhongshan Hospital Xiamen University

View on ClinicalTrials.gov

Summary

The efficacy and safety of the use of Camrelizumab combined with Apatinib

Detailed Description

To evaluate the clinical efficacy and safety of Camrelizumab combined with Apatinib in the treatment of patients with advanced gastric cancer and colorectal cancer. The 62 patients were enrolled in a 2-week regimen with 200mg Camrelizumab given intravenously every two weeks and 250mg apatinib mesylate every 4 weeks for a treatment cycle until progressive or intolerable，then the objective remission rate(ORR) was calculated.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age 18 - 75 years；
•Patients with histologically or cytologically confirmed advanced or metastatic gastric cancer and colorectal cancer.
•Patients who had previously progressed after receiving standard second-line advanced treatment；
•Patients with at least one evaluable or measurable lesions as per RECIST version 1.1 （CT scan length and diameter of tumor lesion≥10mm，CT scan of lymph node lesion was short diameter≥15mm，scan slice thickness 5mm；）
•ECOG performance status (PS) 0 - 2；
•Life expectancy of at least 3 months；
•Patients with adequate organ function at the time of enrollment as defined below:
•1. Blood routine examination standard：（without blood transfusion within 14 days before enrollment）
•1. Hb ≥90g/L，
•2. WBC≥3.0×109/L
+8 more criteria

Exclusion Criteria

•Except for other malignant tumors, basal cell carcinoma of the skin and cervical cancer in situ in the past 5 years；
•Patients who have undergone systemic chemotherapy, radiotherapy, surgery, hormone therapy, or immunotherapy \<2 weeks before enrollment；
•With severe heart, liver, lung and kidney disease；Significant neurological or psychiatric disorders；Patients with partial or complete gastrointestinal obstruction；
•Patients with a large amount of pleural effusion or ascites requiring drainage；
•Patients with symptomatic brain metastasis；
•Patients with hypertension that is difficult to control (systolic blood pressure ≥140 mmHg and diastolic blood pressure ≥90 mmHg) despite treatment with several hypotensive agents; Patients with acute coronary syndrome (including myocardial infarction and unstable angina), and with a history of coronary angioplasty or stent placement performed within 6 months before enrollment；Patients with acute coronary syndrome（included QTc male\>450ms，female\>470ms）and cardiac dysfunction；
•Women who are pregnant or breastfeeding；
•Patients with concurrent autoimmune disease, or a history of chronic or recurrent autoimmune disease;
•Patients with concurrent autoimmune disease, or a history of chronic or recurrent autoimmune disease: included HIV positive or a history of organ transplantation and allogeneic bone marrow transplantation;
•Patients with interstitial lung disease with symptoms or signs of activity；
+7 more criteria

Locations (1)

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, China

Key Dates

Start Date

August 20, 2019

Primary Completion Date

September 23, 2020

Completion Date

October 31, 2021

Last Updated

September 29, 2020

Enrollment

ESTIMATED participants

Conditions

Colorectal Cancer Recurrent

Interventions

Camrelizumab

DRUG

Apatinib

DRUG

Contacts

Li Xiao, Doctor

CONTACT

2292201 xiaolibohan@163.com

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COMPLETEDPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 29, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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