Clinical trial NCT04067986: Camrelizumab Combined With Apatinib in the Treatment of Patients With Advanced Gastric Cancer and Colorectal Cancer
Official title: Camrelizumab Combined With Apatinib in the Treatment of Patients With Advanced Gastric Cancer and Colorectal Cancer：One-arm Exploratory Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Colorectal Cancer Recurrent
Lead sponsor: Zhongshan Hospital Xiamen University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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；

Primary outcomes:
measure: Objective response rate
timeFrame: one year
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse-Events
timeFrame: one year
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Zhongshan Hospital Affiliated to Xiamen University
state: Fujian
Study officials:
affiliation: Zhongshan Hospital Xiamen University
name: Li Xiao, Doctor
role: PRINCIPAL_INVESTIGATOR
References: