FOLFOX Chemotherapy Plus Fruquintinib and Sintilimab After First-line Treatment in Unresectable Hepatocellular Carcinoma

Trial Title: FOLFOX Chemotherapy Plus Fruquintinib and Sintilimab After First-line Treatment in Unresectable Hepatocellular Carcinoma

NCT ID: NCT06446154

Condition: Hepatocellular Carcinoma
Immunotherapy
Anti-angiogenic Therapy
FOLFOX Systemic Chemotherapy
Second-line Treatment

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Intervention model description: FOLFOX systemic chemotherapy plus fruquintinib and sintilimab

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: FOLFOX systemic chemotherapy plus fruquintinib and sintilimab
Description: The current PICC catheterization was unified for patients undergoing FOLFOX systemic chemotherapy. After catheterization, the catheter was connected to the injection pump in the ward and was continuously pumped into the following chemotherapeutic drugs. The chemotherapy was repeated every 3 weeks for a total of 8 courses. Oxaliplatin, 85mg/m2，IV (intra venous)，Day 1. Calcium folinate, 400mg/m2，IV，Day1. 5FU, 400mg/m2, IV, Day1, sequentially 2400mg/m2, IV, lasting for 46 hours. Fruquintinib was given orally for 5mg/ days. After 3 weeks, the drug was stopped for 1 week. Sintilimab was infused intravenously 200mg each time, repeated every three weeks.
Arm group label: FOLFRUS

Summary: Nowadays, there are few second-line treatment options for advanced hepatocellular carcinoma (HCC). In order to further improve the efficacy of second-line treatment for advanced HCC, we plan to conduct a single-arm, single-center and phase II clinical study to explore the efficacy and safety of the new second-line treatment for advanced HCC. Previous studies had shown that FOLFOX systemic chemotherapy tended to increase the median survival time of patients with advanced HCC, and significantly improved the progression-free survival and tumor response rate. Therefore, FOLFOX systemic chemotherapy has become one of the recommended treatments for advanced HCC in Chinese guidelines. A phase II clinical study had showed that sintilimab combined with fruquintinib was with a promising anti-tumor activity in patients with advanced HCC who had received standard treatment, with a median progression-free survival of 7.4 months and a tumor response rate of 31.6%. Furthermore, there was a synergistic effect among chemotherapy, immunotherapy and anti-angiogenic therapy. Our previous phase II study showed that the median progression-free survival was 9.73 months, the median overall survival time was 14.63 months, and the tumor response rate was 43.3% in HCC patients extrahepatic metastasis who received FOLFOX systemic chemotherapy combined with targeted and immunotherapy. The results from our study suggested that the combination therapy had excellent anti-tumor efficacy and safety profile. Therefore. We intend to conduct this clinical study to explore the efficacy and safety of FOLFOX systemic chemotherapy combined with fruquintinib and sintilimab in second-line treatment for patients with unresectable HCC after first-line treatment.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - patients aged 18 years or older - with unresectable, locally advanced, or metastatic HCC, with the diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Disease criteria - who had received previously atezolizumab/sintilimab plus bevacizumab, lenvatinib, sorafenib or camrelizumab plus rivoceranib - had at least on measurable disease, as defined by Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST v1.1) criteria - had a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - had a Child-Pugh liver function score of 7 or less - had adequate hematologic and organ function (absolute neutrophil count ≥1.2×109/l, platelet count ≥60×109/l, total bilirubin < 30μmol/l, albumin ≥ 30g/l, aspartate transaminase and alanine transaminase ≤ 5×upper limit of the normal, creatinine clearance rate of ≤ 1.5×upper limit of the normal, and left ventricular ejection ≥ 45%) Exclusion Criteria: - history of HIV, organ allograft - combined with other malignant tumors - evidence of hepatic decompensation, bleeding diathesis or event - allergy to the investigational agents or any agent given in association with this trial - incomplete medical information.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: July 1, 2024

Completion date: July 1, 2026

Lead sponsor:
Agency: Sun Yat-sen University
Agency class: Other

Source: Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06446154