Status:
UNKNOWN
An Exploratory Trail of Camrelizumab Plus Apatinib Mesylate for Advanced Gastrointestinal
Lead Sponsor:
Harbin Medical University
Conditions:
Gastrointestinal Cancer
Immunotherapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
At present, surgery, radiotherapy and chemotherapy are the main treatment methods for patients with advanced gastrointestinal cancer. Although targeted therapy has significantly improved the prognosis...
Eligibility Criteria
Inclusion
- 1\. Diagnosed as gastric or colorectal adenocarcinoma by histopathology and/or cytology.
- 2\. Patients could not receive surgical resection. 3. Previous standard treatment failure . 4. According to the RECIST v1.1 guide, at least 1 lesions (never received radiotherapy),accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent as the first choice),the longest diameter was more than 10mm (except for the lymph nodes, the short axis of the lymph nodes must be more than 15mm), repeated measurement.
- Eastern Cooperative Oncology Group Performance Status(ECOG PS):0-1 score 6.The main organs function is normal, which meets the following requirements. (1) Blood routine examination,(no blood transfusion within 14 days).
- Hemoglobin(HB)≥90g/L;
- Absolute neutrophil count (ANC) ≥1.5×10\^9/L;
- Blood platelet (PLT)≥80×10\^9/L; (2) Biochemical examination should comply with the following criteria:
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- Bilirubin(BIL) \<1.5 times of the upper limit of normal value (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase(AST)\<2.5\*ULN (liver metastasis ALT and AST\<5\*ULN).
- Serum Cr≤1\*ULN, creatinine clearance rate≥50ml/min(Cockcroft-Gault formula) 7. The expected survival time more than 3 months; 8. The physicians plan to use Camrelizumab Plus Apatinib Mesylate. 9. Patients voluntarily joined the study and signed informed consent form(ICF). 10. Childbearing age women must undergo a negative pregnancy test(serum or urine) within 7 days ,and voluntarily adopt appropriate methods for contraception from the period of under observation and within 8 weeks of the last time they are given the drug;As for men, it is necessary to receive surgical sterilization, or agree to adopt appropriate methods for contraception from the period of under observation and within 8 weeks of the last time they are given the drug.
Exclusion
- There is a case of heart disease in any of the following situations. (1)Recent publications have the following heart disease (within 6 months)
- Acute coronary artery syndrome
- Acute heart failure (grade III or IV of NYHA classification)
- Significant ventricular arrhythmia(sustained ventricular tachycardia, ventricular fibrillation and sudden death after resuscitation).
- (2)The New York Heart Association(NYHA) grade of grade III or IV (3)The patients with severe conduction block, and permanent pacemaker is invalid (two degree and three degree atrioventricular block, sinus arrest) (4)Unexplained syncope occurred within 3 months.
- (5)The researchers identified as uncontrol of severe hypertension, or symptomatic hypertension.
- There are many factors that affect the absorption of oral drugs (such as unable to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction).
- ECOG score≥2
- Abnormal coagulation function (INR\>1.5\*ULN, Activated Partial Thromboplastin Time (APTT)\>1.5\*ULN), with bleeding tendency.
- There is any history of allergy or hypersensitivity in this research's drug or adjuvant.
- HIV infection and/or active hepatitis B virus infection.
- Any condition that may damage the safety of patients or the integrity of research data, including serious medical risk factors, physical condition and laboratory abnormality.
- The high risk population carrying UGT1A1\*28 (7/7) \*6 (A/A) genotype or simultaneous carrying of the UGT1A1\*28 (6/7) \*6 (A/G) genotype (the heterozygous genotype) suggests the exclusion of the Irinotecan
- Pregnant or lactating women;
- Other conditions which the doctor think not suitable for inclusion.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05225844
Start Date
January 1 2019
End Date
October 1 2022
Last Update
February 7 2022
Active Locations (1)
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1
Harbin Medical University
Harbin, Heilongjiang, China