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

NCT05643417 | Unknown Phase 1

• 1 other identifier: 22-OBU-SH-CA-II-019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Metastatic Liver Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• DCR

  24 months

• PFS

  24 months

• OS

  24 months

Study Arms (9)

Liver metastasis of gastric cancer

EXPERIMENTAL

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

Drug: HAIC、Bevacizumab、Camrelizumab

Liver metastasis of breast cancer

EXPERIMENTAL

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

Drug: HAIC、Bevacizumab、Camrelizumab

Liver metastasis of lung cancer

EXPERIMENTAL

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

Drug: HAIC、Bevacizumab、Camrelizumab

Liver metastasis of nasopharyngeal carcinoma

EXPERIMENTAL

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

Drug: HAIC、Bevacizumab、Camrelizumab

Liver metastasis of thyroid cancer

EXPERIMENTAL

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

Drug: HAIC、Bevacizumab、Camrelizumab

Liver metastasis of melanoma

EXPERIMENTAL

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

Drug: HAIC、Bevacizumab、Camrelizumab

Liver metastasis of stromal tumor

EXPERIMENTAL

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

Drug: HAIC、Bevacizumab、Camrelizumab

Liver metastasis of sarcoma

EXPERIMENTAL

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

Drug: HAIC、Bevacizumab、Camrelizumab

Liver metastasis of other solid tumor

EXPERIMENTAL

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

Drug: HAIC、Bevacizumab、Camrelizumab

Interventions

HAIC、Bevacizumab、Camrelizumab DRUG

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

Also known as: Camrelizumab brand name: ai rui ka; Bevacizumab brand name: ai rui tuo

Liver metastasis of breast cancer; Liver metastasis of gastric cancer; Liver metastasis of lung cancer; Liver metastasis of melanoma; Liver metastasis of nasopharyngeal carcinoma; Liver metastasis of other solid tumor; Liver metastasis of sarcoma; Liver metastasis of stromal tumor; Liver metastasis of thyroid cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent has been signed
• Age ≥ 18 years old
• 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
• The investigator assessed that the liver metastasis could not be removed surgically
• Progression or intolerance after receiving standard systemic therapy (patients who have received first-line immunotherapy can still be enrolled)
• Child-Pugh score ≤ 7
• At least one measurable lesion (according to RECIST 1.1)
• Expected overall survival ≥ 3 months
• ECOG PS score: 0\~1
• 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)
• Women of childbearing age must take contraceptive measures within 3 months from the first dose to the last use of the study drug

You may not qualify if:

• 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)
• Patients had a history of organ transplantation or hepatic encephalopathy
• 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
• Patients who are seriously allergic to iodized contrast agents, antibody drugs, calcium folinate, 5-FU, platinum drugs , (≥ grade 3)
• Participated in other clinical trials or received other test drugs within 4 weeks before the first administration
• Pregnant or lactating women or women of childbearing age are positive in the baseline pregnancy test
• Other factors that may affect the subject's safety or test compliance as judged by the investigator

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200062, China

Location

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Lu Wang

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Tan

CONTACT

15800680751; 121176421@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: December 8, 2022
• Study Start: December 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2024
• Last Updated: December 8, 2022

Record last verified: 2022-12

Locations

CN (1)