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

NCT04067986 | Unknown Phase 1

• 1 other identifier: Arise-FJ-R301
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1, and immune-related (ir) RECIST

  one year

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse-Events

  one year

Study Arms (1)

Camrelizumab + Apatinib

OTHER

Camrelizumab + Apatinib

Drug: Camrelizumab; Drug: Apatinib

Interventions

Camrelizumab DRUG

Camrelizumab One course will last 28 days.Intravenous injection at a dose of 200 mg, q2w One course will last 28 days. Oral administration at a dose of 250 mg/d

Also known as: Apatinib

Camrelizumab + Apatinib

Apatinib DRUG

Apatinib One course will last 28 days.Oral administration at a dose of 250 mg, qd

Camrelizumab + 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:

• 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:
• Blood routine examination standard：（without blood transfusion within 14 days before enrollment）
• Hb ≥90g/L，
• WBC≥3.0×109/L
• ANC ≥ 1.5×109/L，
• PLT ≥ 80×109/L；
• Biochemical examination shall meet the following standards：
• BIL \<1.5 times the upper limit of normal（ULN），
• ALT and aspartate aminotransferase (AST) \<2.5×upper limit of normal (ULN)，If liver metastasis is present，ALT and AST\<5ULN ；

You may not qualify if:

• 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；
• Urine protein ≥ ++ or confirmed 24 hour urine protein quantitation；
• Patients with non-healing wound, non-healing ulcer, or non-healing bone fracture;
• Patients with a seizure disorder who require pharmacotherapy；
• Patients with a history of hypersensitivity to any of the study drugs, similar drugs, or excipients；
• The investigator believes that there are any conditions that may damage the subject or result in the subject being unable to meet or perform the research request;

Sponsors & Collaborators

• Zhongshan Hospital Xiamen University: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Interventions

camrelizumab; apatinib

Study Officials

• Li Xiao, Doctor

  Zhongshan Hospital Xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Xiao, Doctor

CONTACT

2292201; xiaolibohan@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 28, 2019
• Study Start: August 20, 2019
• Primary Completion: September 23, 2020
• Study Completion: October 31, 2021
• Last Updated: September 29, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)