Adjuvant Immunotherapy With Toripalimab Following Curative-intent Ablation for Recurrent Hepatocarcinoma

NCT05240404 | Unknown Phase 2 DMC

• 1 other identifier: IRTOE
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II study is to evaluate the efficacy of the adjuvant immunotherapy after curative-intent ablation for recurrent hepatocarcinoma

Conditions

Hepatocellular Carcinoma

Keywords

Immunotherapy; Toripalimab

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  Disease-free survival was defined as the interval from the date of randomization to date of detection new recurrent disease

  up to 3 years until study closed

Secondary Outcomes (3)

• Overall survival

  up to 3 years until study closed

• Number of participants with adverse events

  Up to approximately 3 years

• Predictive Biomarkers

  Up to approximately 3 years

Study Arms (2)

Arm A

OTHER

Patients with recurrent hepatocellular carcinoma would be treated with curative-intent ablation alone.

Procedure: Thermal ablation

Arm B

EXPERIMENTAL

Patients with recurrent hepatocellular carcinoma would be treated with curative-intent ablation and adjuvant immunotherapy with toripalimab.

Drug: Toripalimab; Procedure: Thermal ablation

Interventions

Toripalimab DRUG

toripalimab treatment (240mg intravenously every 3 weeks) started on day 3 after ablation for six months

Also known as: Immunotherapy

Arm B

Thermal ablation PROCEDURE

The ablation operation was performed under local or compound anesthesia and guided by ultrasonography (US) or computed tomography (CT). To ensure complete destruction of the tumor, the ablation area must exceed the tumor boundary 1.0 cm.

Also known as: Local treatment

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HCC diagnosed as (i) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level greater than 200 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms, or (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 200 IU/ml, and a radiologically compatible feature with HCC in two or more CT/MRI/angiograms or (iii) histological confirmation.
• HCC patients who had recurrent or residual tumor after other treatments without evidence of extrahepatic metastasis the largest diameter of tumor should be less than 3cm, and the number of tumor ≤2 no previous treatment to target tumors by other forms of RT.
• liver function of Child-Pugh class A or B7 (Child-Pugh score of ≤7). performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score.
• WBC count ≥ 2,000/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 50,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dL; AST and ALT \< 5.0× upper limit of normal; no ascites).
• no serious comorbidities other than liver cirrhosis. written informed consent.

You may not qualify if:

• HCC diagnosed as (i) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level greater than 200 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms, or (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 200 IU/ml, and a radiologically compatible feature with HCC in two or more CT/MRI/angiograms or (iii) histological confirmation.
• HCC patients who had recurrent or residual tumor after other treatments without evidence of extrahepatic metastasis the largest diameter of tumor should be less than 3cm, and the number of tumor ≤2 no previous treatment to target tumors by other forms of RT.
• Liver function of Child-Pugh class A or B7 (Child-Pugh score of ≤7). Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score.
• WBC count ≥ 2,000/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 50,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dL; AST and ALT \< 5.0× upper limit.
• Written informed consent.
• Exlusion criteria:
• Evidence of extrahepatic metastasis. Liver function of Child-Pugh class B8-9 and C (Child-Pugh score of \>7). Previous history of other forms of RT adjacent to target tumors. Poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG) score.
• Pregnant or breast feeding status. Previous history uncontrolled other malignancies within 2 years.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital, Central South University

Changsha, Hunan, 410005, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

toripalimab; Immunotherapy; Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics; Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Liangrong Shi, M.D.

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liangrong Shi, M.D.

CONTACT

+8613974886662; shiliangrong@126.com

Study Design

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

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 15, 2022
• Study Start: July 1, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2024
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

CN (1)