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

• Status: Recruiting
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhongshan Hospital Xiamen University
• Treatments: Apatinib

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；