A Single-arm, Open-label, Multi-center Phase II Clinical Study to Evaluate the Safety and Efficacy of Toripalimab Injection (JS001) Combined With Bevacizumab as the First-line Therapy for Advanced Hepatocellular Carcinoma (HCC)

NCT04605796 | Unknown Phase 2

• 1 other identifier: JS001-034-II-HCC
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single-arm, national multicenter phase II clinical study to preliminarily observe and evaluate the efficacy and safety of Toripalimab combined with Bevacizumab as the first-line therapy for advanced HCC The study will use safety/tolerability and ORR as the primary study objectives and indicators, and plans to enroll about 50-60 patients.

Conditions

Advanced Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Frequency table will be used to summarize occurrence of each treatment-emergent AE

  Up to 2 years

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Number and incidence of abnormal laboratory examinations by treatment group.

  Up to 2 years

• ORR

  The rate of participants that achieve either a complete response (CR) or a partial response (PR).

  Up to 2 years

Secondary Outcomes (5)

• DoR

  Up to 2 years

• DCR

  Up to 2 years

• TTP

  Up to 2 years

• PFS

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

Other Outcomes (4)

• PD-L1

  Up to 2 years

• TMB

  Up to 2 years

• PK

  Up to 2 years

Study Arms (1)

Single Arm

EXPERIMENTAL

Experimental group: Toripalimab combined with Bevacizumab

Combination Product: Toripalimab combined with Bevacizumab

Interventions

Toripalimab combined with Bevacizumab COMBINATION_PRODUCT

Experimental group: Toripalimab, 240mg, IV infusion, every 3 weeks (q3w). combined with Lenvatinib 15 mg/kg (IV infusion, every 3 weeks (q3w).. Continuous infusion, in a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol.

Single Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18-70 years (inclusive), male or female.
• HCC diagnosed by histopathological examination or Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2017 Edition).
• Stage B (middle stage) or C (late stage) HCC determined in accordance with Barcelona Clinic Liver Cancer staging system (BCLC stage). In case of stage B, the patient must be unsuitable for surgery and/or local therapy, or have progressive disease after surgery and/or local therapy, or refuse surgery and/or local therapy (special instruction and signature required).
• No previous use of any systemic therapy or HCC.
• Having ≥ 1 measurable lesion in accordance with RECISTv1.1.
• Grade A Child-Pugh hepatic function, with no history of hepatic encephalopathy.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 0-1.
• Expected survival ≥12 weeks.
• Adequate hematologic and end-organ function..
• In case of HBsAg (+) and/or HBcAb (+), HBV DNA is required to be \< 500 IU/mL, and it is required to continue the effective anti-HBV therapy that has been adopted in the full course, or start to use Entecavir or tenofovir in the full course during the study. HBV/HCV co-infected patients will be excluded. Patients with a history of HCV infection but with negative HCV RNA PCR results can be considered uninfected with HCV.
• Female patients of childbearing potential must receive serum pregnancy test within 7 days before enrollment, have negative result, and agree to use reliable and effective contraceptive methods during the trial and within 60 days after the last dose of study drug. The male patients whose partners are women of childbearing potential must agree to use reliable and effective contraceptive methods during the trial and within 60 days after the last dose of study drug.
• Being voluntary to participate in the study, sufficiently informed consent and signature of written informed consent form, with good compliance.
• Patients can not be enrolled in the study if any one of the following criteria is fulfilled:
• Known cholangiocellular carcinoma (ICC) or mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma and hepatic fibrolamellar carcinoma.
• Malignant tumor except HCC in the past 5 years: however, localized tumor cured in the study is excluded, including cervical carcinoma in situ, skin basal cell carcinoma and carcinoma in situ of prostate.

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (1)

Beijing Cancer hospital

Beijing, China

Location

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 28, 2020
• Study Start: April 10, 2020
• Primary Completion: December 22, 2020
• Study Completion: December 31, 2022
• Last Updated: November 24, 2021

Record last verified: 2021-11

Locations

CN (1)