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

NCT ID: NCT05643417

Last Updated: 2022-12-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2024-10-31

Brief 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

Detailed 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

Conditions

Metastatic Liver Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liver metastasis of gastric cancer

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

Group Type: EXPERIMENTAL

HAIC、Bevacizumab、Camrelizumab

Intervention Type: DRUG

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

Liver metastasis of breast cancer

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

Group Type: EXPERIMENTAL

HAIC、Bevacizumab、Camrelizumab

Intervention Type: DRUG

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

Liver metastasis of lung cancer

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

Group Type: EXPERIMENTAL

HAIC、Bevacizumab、Camrelizumab

Intervention Type: DRUG

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

Liver metastasis of nasopharyngeal carcinoma

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

Group Type: EXPERIMENTAL

HAIC、Bevacizumab、Camrelizumab

Intervention Type: DRUG

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

Liver metastasis of thyroid cancer

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

Group Type: EXPERIMENTAL

HAIC、Bevacizumab、Camrelizumab

Intervention Type: DRUG

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

Liver metastasis of melanoma

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

Group Type: EXPERIMENTAL

HAIC、Bevacizumab、Camrelizumab

Intervention Type: DRUG

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

Liver metastasis of stromal tumor

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

Group Type: EXPERIMENTAL

HAIC、Bevacizumab、Camrelizumab

Intervention Type: DRUG

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

Liver metastasis of sarcoma

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

Group Type: EXPERIMENTAL

HAIC、Bevacizumab、Camrelizumab

Intervention Type: DRUG

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

Liver metastasis of other solid tumor

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

Group Type: EXPERIMENTAL

HAIC、Bevacizumab、Camrelizumab

Intervention Type: DRUG

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

Interventions

HAIC、Bevacizumab、Camrelizumab

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

Intervention Type: DRUG

Other Intervention Names

Camrelizumab brand name: ai rui ka; Bevacizumab brand name: ai rui tuo

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Lu Wang, MD, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lu Wang

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Li Tan

Role: CONTACT

121176421@qq.com

15800680751

Other Identifiers

22-OBU-SH-CA-II-019

Identifier Type: -

Identifier Source: org_study_id