Camrelizumab Combined With Bevacizumab and HAIC in Patients With Metastatic Liver Cancer Who Failed Standard Therapy

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single center, multi-cohort, phase I basket trial to evaluate the safety and efficacy of camrelizumab in combination with bevacizumab and HAIC for metastatic liver cancer after standard treatment failure

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

Details

• Lead Sponsor: Fudan University
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

1. Informed consent has been signed

2. Age ≥ 18 years old

3. Liver metastases of solid tumors confirmed by histology or cytology (including but not limited to gastric cancer, breast cancer, lung cancer, nasopharyngeal cancer, thyroid cancer, melanoma, stromal tumor, sarcoma, etc.), including liver metastases at the time of diagnosis or liver metastases occurred after radical resection, and the primary tumor has been resected

4. The investigator assessed that the liver metastasis could not be removed surgically

5. Progression or intolerance after receiving standard systemic therapy (patients who have received first-line immunotherapy can still be enrolled)

6. Child-Pugh score ≤ 7

7. At least one measurable lesion (according to RECIST 1.1)

8. Expected overall survival ≥ 3 months

9. ECOG PS score: 0~1

10. Has sufficient organ function within 14 days before the first administration, (1) Blood routine: WBC≥3.0×109/L; ANC≥1.5×109/L; PLT≥50×109/L; HGB≥90 g/L (2) Liver function: AST≤5.0×ULN; ALT≤5.0×ULN; TBIL≤2.0×ULN (3) Renal function: Cr≤1.5×ULN or CrCl ≥60 mL/min (4) Coagulation function: INR≤1.5; APTT≤1.5×ULN (5) HBV-DNA≤2×103 IU/ml (subjects with HBV-DNA>2×103 IU/ml can be enrolled and should receive antiviral treatment at the same time)

11. Women of childbearing age must take contraceptive measures within 3 months from the first dose to the last use of the study drug

Exclusion Criteria:

1. Patients had other malignant tumors in the past or at the same time (excluding non melanoma skin cancer, cervical carcinoma in situ, papillary thyroid cancer after treatment)

2. Patients had a history of organ transplantation or hepatic encephalopathy

3. Suffering from immunodeficiency disease within 7 days before the first administration, or receiving systemic hormone treatment (≥ 10mg/day prednisone or equivalent dose of other hormones), or other forms of immunosuppressive treatment

4. Patients who are seriously allergic to iodized contrast agents, antibody drugs, calcium folinate, 5-FU, platinum drugs , (≥ grade 3)

5. Participated in other clinical trials or received other test drugs within 4 weeks before the first administration

6. Pregnant or lactating women or women of childbearing age are positive in the baseline pregnancy test

7. Other factors that may affect the subject's safety or test compliance as judged by the investigator