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

Sponsor
Fudan University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05643417
Collaborator
(none)
80
Enrollment
1
Location
9
Arms
22
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Liver metastasis of gastric cancer

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

Drug: HAIC、Bevacizumab、Camrelizumab
HAIC: refer to genetic test results，D1 Bevacizumab：7.5mg/Kg, D2, Q3W Camrelizumab：200mg, D2, Q3W
Other Names:
  • Camrelizumab brand name: ai rui ka; Bevacizumab brand name: ai rui tuo

    		•
    Experimental: Liver metastasis of breast cancer

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

    Drug: HAIC、Bevacizumab、Camrelizumab
    HAIC: refer to genetic test results，D1 Bevacizumab：7.5mg/Kg, D2, Q3W Camrelizumab：200mg, D2, Q3W
    Other Names:
  • Camrelizumab brand name: ai rui ka; Bevacizumab brand name: ai rui tuo

    		•
    Experimental: Liver metastasis of lung cancer

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

    Drug: HAIC、Bevacizumab、Camrelizumab
    HAIC: refer to genetic test results，D1 Bevacizumab：7.5mg/Kg, D2, Q3W Camrelizumab：200mg, D2, Q3W
    Other Names:
  • Camrelizumab brand name: ai rui ka; Bevacizumab brand name: ai rui tuo

    		•
    Experimental: Liver metastasis of nasopharyngeal carcinoma

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

    Drug: HAIC、Bevacizumab、Camrelizumab
    HAIC: refer to genetic test results，D1 Bevacizumab：7.5mg/Kg, D2, Q3W Camrelizumab：200mg, D2, Q3W
    Other Names:
  • Camrelizumab brand name: ai rui ka; Bevacizumab brand name: ai rui tuo

    		•
    Experimental: Liver metastasis of thyroid cancer

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

    Drug: HAIC、Bevacizumab、Camrelizumab
    HAIC: refer to genetic test results，D1 Bevacizumab：7.5mg/Kg, D2, Q3W Camrelizumab：200mg, D2, Q3W
    Other Names:
  • Camrelizumab brand name: ai rui ka; Bevacizumab brand name: ai rui tuo

    		•
    Experimental: Liver metastasis of melanoma

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

    Drug: HAIC、Bevacizumab、Camrelizumab
    HAIC: refer to genetic test results，D1 Bevacizumab：7.5mg/Kg, D2, Q3W Camrelizumab：200mg, D2, Q3W
    Other Names:
  • Camrelizumab brand name: ai rui ka; Bevacizumab brand name: ai rui tuo

    		•
    Experimental: Liver metastasis of stromal tumor

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

    Drug: HAIC、Bevacizumab、Camrelizumab
    HAIC: refer to genetic test results，D1 Bevacizumab：7.5mg/Kg, D2, Q3W Camrelizumab：200mg, D2, Q3W
    Other Names:
  • Camrelizumab brand name: ai rui ka; Bevacizumab brand name: ai rui tuo

    		•
    Experimental: Liver metastasis of sarcoma

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

    Drug: HAIC、Bevacizumab、Camrelizumab
    HAIC: refer to genetic test results，D1 Bevacizumab：7.5mg/Kg, D2, Q3W Camrelizumab：200mg, D2, Q3W
    Other Names:
  • Camrelizumab brand name: ai rui ka; Bevacizumab brand name: ai rui tuo

    		•
    Experimental: Liver metastasis of other solid tumor

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

    Drug: HAIC、Bevacizumab、Camrelizumab
    HAIC: refer to genetic test results，D1 Bevacizumab：7.5mg/Kg, D2, Q3W Camrelizumab：200mg, D2, Q3W
    Other Names:
  • Camrelizumab brand name: ai rui ka; Bevacizumab brand name: ai rui tuo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence and degree of Adverse Events and Serious Adverse Events [24 months]

      Incidence, severity, and relationship to study drugs of all adverse events (AEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs).

    2. ORR [24 months]

      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.

    Secondary Outcome Measures

    1. DCR [24 months]

      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

    2. PFS [24 months]

      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

    3. OS [24 months]

      overall survival(OS), defined as the time from enrollment to death due to any cause.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fudan University Shanghai Cancer Center Shanghai Shanghai China 200062

    Sponsors and Collaborators

    • Fudan University

    Investigators

    • Principal Investigator: Lu Wang, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lu Wang, MD, PhD, Professor, Fudan University
    ClinicalTrials.gov Identifier:
    NCT05643417
    Other Study ID Numbers:
    • 22-OBU-SH-CA-II-019
    First Posted:
    Dec 8, 2022
    Last Update Posted:
    Dec 8, 2022
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Neoplasms
    Bevacizumab

    Study Results

    No Results Posted as of Dec 8, 2022