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

Metastatic Liver Cancer Clinical Trial

Official title:

A Single Center, Multi Cohort, Phase I Basket Trial of the Safety and Efficacy of Camrelizumab in Combination With Bevacizumab and HAIC for Metastatic Liver Cancer After Standard Treatment Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05643417
• Other study ID #: 22-OBU-SH-CA-II-019
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 2022
• Est. completion date: October 2024

Study information

• Verified date: December 2022
• Source: Fudan University
• Contact: Li Tan
• Phone: 15800680751
• Email: 121176421[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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 treatment for many cancers; referring to the expert consensus on liver metastasis of solid tumors and ongoing clinical research, the "PD-1 + anti-angiogenesis + HAIC" regimen can be used as a new research direction for posterior treatment for metastatic liver cancer.

In view of the failure of first-line chemotherapy, how to find effective chemotherapy drugs has become a top priority. HAIC guided by genetic testing may be able to screen out effective chemotherapy drugs

This study is an open-label, single-center, multi-cohort, phase I basket trial designed to explore safety and efficacy of "camrelizumab + bevacizumab + HAIC guided by genetic testing" for metastatic liver cancer after standard treatment failure

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Neoplasms
• Metastatic Liver Cancer

Intervention

Drug:
• HAIC?Bevacizumab?Camrelizumab
HAIC: refer to genetic test results,D1 Bevacizumab:7.5mg/Kg, D2, Q3W Camrelizumab:200mg, D2, Q3W

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and degree of Adverse Events and Serious Adverse Events	Incidence, severity, and relationship to study drugs of all adverse events (AEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs).	24 months
Primary	ORR	objective response rate(ORR),defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.	24 months
Secondary	DCR	disease control rate(DCR), defined as the percentage of participants who have a confirmed complete response(CR) or partial response(PR) or stable disease(SD) per RECIST 1.1 as assessed by investigator	24 months
Secondary	PFS	progression-free survival(PFS), defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator	24 months
Secondary	OS	overall survival(OS), defined as the time from enrollment to death due to any cause.	24 months