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Real world clinical study of carrelizumab in the treatment of recurrent or metastatic colorectal cancer

Real world clinical study of carrelizumab in the treatment of recurrent or metastatic colorectal cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100050182
Enrollment
Unknown
Registered
2021-08-21
Start date
2021-08-17
Completion date
Unknown
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer

Interventions

case group:Nil

Sponsors

Quanzhou Guangqian Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18 to 75 years; 2. Recurrent / metastatic colorectal cancer confirmed by pathology (including histology or cytology); 3. Patients who have previously received second-line standard chemotherapy or targeted therapy; 4. According to recist1.1 standard, the patient has at least one target lesion with measurable diameter line (the long diameter of CT scanning of tumor lesions >=10mm, the short diameter of CT scanning of lymph node lesions >=15mm, and the thickness of scanning layer is 5mm); 5. ECOG score 0-2; 6. Estimated survival time >=3 months; 7. Patients who are considered by doctors to be likely to benefit from the adjuvant treatment of carrelizumab combined with apatinib and TACE and voluntarily receive treatment; 8. The main organs function normally and meet the following standards: (1) Blood routine examination standards shall meet: (no blood transfusion within 14 days); 1) HB>=90g/L; 2) WBC>=3.0x10^9/L; 3) ANC>=1.5x10^9/L; 4) PLT>=80x10^9/L; (2) Biochemical examination shall meet the following standards: 1) BIL 50ml/min (Cockcroft Gault formula); 9. Women of childbearing age must have a pregnancy test (serum) within 7 days before enrollment, and the result is negative, and are willing to use appropriate contraceptive methods during the test and 8 weeks after the last administration of the test drug; for men, surgical sterilization or consent to appropriate contraceptive methods during the trial and 8 weeks after the last administration of the trial drug; 10. Did not participate in other clinical studies before and during treatment; 11. The observed patients voluntarily joined the study, signed informed consent, had good compliance and cooperated with follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with other malignant diseases in recent 5 years, except cured skin cancer and cervical carcinoma in situ; 2. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors; 3. Currently participating in intervention clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration; 4. Patients with massive pleural effusion or ascites requiring drainage within 2 weeks after the first medication; 5. There is uncontrolled or symptomatic active central nervous system (CNS) metastasis, which can be characterized by clinical symptoms, brain edema, Spinal Cord Compressive meningitis, leptomeningeal disease and / or progressive growth. For CNS metastasis, after adequate treatment, and neurological symptoms can return to the baseline level at least 2 weeks before randomization (residual signs or symptoms related to CNS treatment can be included in the study. In addition, the observed patients must stop corticosteroids or receive a stable dose of 450ms, female > 470ms) and cardiac insufficiency; (2) Patients with hypertension who cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure > 140mmHg, diastolic blood pressure > 90mmHg); (3) Poor control of diabetes (fasting plasma glucose (FBG) > 10mmol/L); (4) Patients with positive urinary protein (urinary protein test 2 + or more, or 24-hour urinary protein quantification > 1.0g); (5) Patients with uncontrolled epilepsy, central nervous system diseases or mental disorders; (6) Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before enrollment; (7) A history of noninfectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or the current presence of clinically active interstitial lung disease; (8) There are active or uncontrolled infections requiring whole blood treatment; (9) Active pulmonary tuberculosis; (10) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; (11) There were clinically active diverticulitis, abdominal abscess and gastrointestinal obstruction; 7. Patients with autoimmune diseases or history of chronic or recurrent immune diseases, including history of immune deficiency, such as HIV positive or history of organ transplantation and allogeneic bone marrow transplantation; 8. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number at the same time was higher than the upper limit of normal value in the laboratory of the research center). 9. Patients with active HCV infection were observed (HCV antibody was positive and HCV-RNA level was higher

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;

Secondary

MeasureTime frame
Progress Free Survival;Disease Control Rate;Overall Survival;Security;

Countries

China

Contacts

Public ContactWu Qingyi

Quanzhou Guangqian Hospital

qqwuqingyi@163.com+86 18150517173

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026