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

NCT ID: NCT04067986

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-20
• Study Completion Date: 2021-10-31

Brief 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.

Conditions

Colorectal Cancer Recurrent

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Camrelizumab + Apatinib

Camrelizumab + Apatinib

Group Type: OTHER

Camrelizumab

Intervention Type: 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

Apatinib

Intervention Type: DRUG

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

Interventions

Camrelizumab

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

Intervention Type: DRUG

Apatinib

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

Intervention Type: DRUG

Other Intervention Names

Apatinib

Eligibility Criteria

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

3. ANC ≥ 1.5×109/L，

4. PLT ≥ 80×109/L；

2. Biochemical examination shall meet the following standards：

1. BIL <1.5 times the upper limit of normal（ULN），

2. ALT and aspartate aminotransferase (AST) <2.5×upper limit of normal (ULN)，If liver metastasis is present，ALT and AST<5ULN ；

3. Serum creatinine Cr≤1ULN，Serum creatinine >50ml/min（Cockcroft-Gault math）

• Women of childbearing age in the serum or urine pregnancy test is negative within 7 days prior to study enrollment and must be Non-lactating patients，and agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 8 months after the end of the study； males should agree to patients who must use contraception during the study period and within 8 months after the end of the study period
• Subjects voluntarily joined the study, signed informed consent, good compliance, and followed up;

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；
• Patients with a risk of gastrointestinal bleeding may not be enrolled, including the following: (1) active digestive ulcer lesions and fecal occult blood (++); (2) nausea and hematemesis within 2 months Medical history. Simple fecal occult blood (+) is not an exclusion criterion；Coagulation abnormalities （INR>1.5、APTT>1.5ULN）；
• 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;
• participated in other clinical studies before and during treatment；

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongshan Hospital Xiamen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Xiao, Doctor

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Hospital Xiamen University

Locations

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Li Xiao, Doctor

Role: CONTACT

xiaolibohan@163.com

2292201 ext. 0592

Facility Contacts

Shuntian Cai

Role: primary

nktianxingjian@163.com

+86 18030190632

Other Identifiers

Arise-FJ-R301

Identifier Type: -

Identifier Source: org_study_id