Donafenib Combine With Sintilimab and HAIC (Hepatic Artery Infusion Chemotherapy，HAIC）in the First-line Treatment of Unresectable Hepatocellular Carcinoma

NCT05166772 | Unknown Phase 2

• 1 other identifier: E20210872
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators design a phase IIB clinical study to explore the efficacy and safety of Donafenib combined with Sintilimab and HAIC in the first-line treatment of unresectable hepatocellular carcinoma

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; HAIC; Sintilimab; Donafenib

Outcome Measures

Primary Outcomes (1)

• ORR（Objective Response Rate）

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

  1 year

Secondary Outcomes (6)

• OS（Overall survival）

  3 years

• TTP（Time to progress）

  3 years

• PFS（Progress free survival）

  3 years

• DCR（Disease control rate）

  3 years

• DOR（Duration of response）

  3 years

Study Arms (1)

Donafenib combined with Sintilimab and HAIC

EXPERIMENTAL

Donafenib：200mg bid； Sintilimab：200mg Q3D； HAIC：Q3W；

Drug: Donafenib; Drug: Sintilimab; Other: HAIC

Interventions

Donafenib DRUG

200 mg BID，oral administration will start before the first HAIC treatment.

Donafenib combined with Sintilimab and HAIC

Sintilimab DRUG

200 mg，Q3W，Intravenous infusion will performe before HAIC treatment.

Donafenib combined with Sintilimab and HAIC

HAIC OTHER

Q3W. The total number of HAIC treatments was determined by the investigator based on patient needs. Dose: Oxaliplatin 85 mg / m2 for 2h, Calcium folinate 400 mg / m2 for 2h, 5-FU 400 mg / m2 for 10min, followed by 5-FU 1200 mg / m2 for 23 hours);

Donafenib combined with Sintilimab and HAIC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily join the study and sign the informed consent;
• Age 18 \~ 80 years old (including 80 years old), male and female;
• Patients with hepatohcellular carcinoma diagnosed clinically or confirmed by histology / cytology according to the code for diagnosis and treatment of primary liver cancer (2019 Edition);
• Patients with unresectable or metastatic hepatocellular carcinoma;
• No systematic treatment. If receiving adjuvant chemotherapy after local treatment more than 12 months, and patients with disease progression or metastasis can also be included in the group;
• The end time of the last intervention, radiotherapy and ablation should be \> 4 weeks;
• Patients who underwent hepatectomy in the past should be R0 resection, and the tumor recurrence should be more than 24 months after operation;
• At least one assessable lesion (RECIST 1.1 criteria);
• Expected survival time ≥ 3 months;
• ECOG 0 \~ 1;
• Child Pugh ≤ 7;
• Be able to cooperate to observe adverse events;
• Major organs are functioning normally.
• Hemoglobin ≥ 90 g / L;
• ANC ≥ 1.5 × 109/L；

You may not qualify if:

• Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components confirmed by histology / cytology in the past;
• Have a history of malignancy other than hepatocellular carcinoma unless the following criteria are met:
• A) The patient has received possible curative treatment and there is no evidence of the disease within 5 years; B) Successful resection of basal cell carcinoma of skin, squamous cell carcinoma of skin, superficial bladder carcinoma, carcinoma in situ of cervix and other cancers in situ
• Diffuse tumor lesions;
• Tumor vascular invasion occurs in one or more of the following situations:
• Involving superior mesenteric vein;
• Involving inferior vena cava;
• History of hepatic encephalopathy, hepatorenal syndrome, or history of liver transplantation;
• Pleural effusion, ascites and pericardial effusion with clinical symptoms requiring drainage;
• Central system metastasis;
• Previous history of severe mental illness;
• Have a disease that affects absorption, distribution, metabolism, or clearance of the drug under study (such as severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc.);
• Previous allogeneic stem cell or parenchymal organ transplantation;
• Previously received targeted therapy of anti VEGF and / or signal pathways such as VEGFR, RAF and MEK, such as sorafenib, renvatinib and regofinib, or immunomodulator therapy such as anti-PD-1, anti-PD-L1 and anti-CTLA-4;
• Patients who have received other anti-tumor systemic treatment in the past, including traditional Chinese medicine with anti-tumor indications less than 2 weeks before the administration of this study, or the adverse events caused by previous treatment have not recovered to ≤ CTCAE level 1; The toxicity of previous anti-tumor treatment did not include grade 1 / 2 neurotoxicity and hair loss caused by oxaliplatin;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Related Publications (1)

• Gao W, Pan ZL, Zhao XH, Yang L, Cao JB, Li DY, Zheng HJ, Liu C, Li GT, Bao X, Liu XM, Zhang WH, Zhu XL, Xiao BH, Song TQ, Li Q, Lu W, Xing WG, Zhang W. Donafenib and sintilimab combined with hepatic arterial infusion chemotherapy for unresectable hepatocellular carcinoma: a prospective, single-arm phase II trial (DoHAICs study). EClinicalMedicine. 2025 May 5;83:103217. doi: 10.1016/j.eclinm.2025.103217. eCollection 2025 May.

  PMID: 40475000 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

donafenib; sintilimab

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

Central Study Contacts

WEI ZHANG, Doctor

CONTACT

18622025401; zhangweitjch@163.com

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: November 29, 2021
• First Posted: December 22, 2021
• Study Start: December 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: December 22, 2021

Record last verified: 2021-11