Camrelizumab Combined With Bevacizumab and HAIC in Patients With Metastatic Liver Cancer Who Failed Standard Therapy
Launched by FUDAN UNIVERSITY · Dec 7, 2022
Trial Information
Current as of January 14, 2025
Unknown status
Keywords
ClinConnect Summary
For patients with advanced primary liver cancer, immunotherapy combined anti-angiogenic therapy has gradually become the first-line standard treatment. However, for metastatic liver cancer, especially after first-line treatment failure, the current treatment options are mostly systemic chemotherapy, and there is still a lack of effective treatment methods. Compared with systemic chemotherapy, HAIC has a higher objective response rate and survival rate, and the incidence of adverse reactions is lower. At the same time, PD-1 combined with chemotherapy has become the first-line standard treatm...
Gender
ALL
Eligibility 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
Trial Officials
Lu Wang
Principal Investigator
Fudan University
About Fudan University
Fudan University, a prestigious comprehensive research university located in Shanghai, China, is committed to advancing medical science through innovative clinical research. Renowned for its rigorous academic standards and cutting-edge research facilities, Fudan University plays a pivotal role in the global health landscape by sponsoring a diverse array of clinical trials aimed at improving patient outcomes and addressing pressing medical challenges. Leveraging its multidisciplinary expertise and collaborative networks, the university strives to translate scientific discoveries into practical applications, fostering advancements in healthcare and contributing to the well-being of communities both locally and internationally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, , China
Shanghai, Shanghai, China
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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