The DoHAICs Study Expansion Phase (NCT07584018) | Clinical Trial Compass
Not Yet RecruitingPhase 2
The DoHAICs Study Expansion Phase
90 participantsStarted 2026-05-20
Plain-language summary
We explored the efficacy and safety of the first-line treatment of unresectable hepatocellular carcinoma with donafenib combined with hepatic artery infusion chemotherapy (HAIC) and sintilimab .
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Voluntarily participate in the trial and provide written informed consent.
* Age between 18 and 80 years (inclusive), regardless of gender.
* Patients with hepatocellular carcinoma (HCC) clinically diagnosed per the "Standard for Diagnosis and Treatment of Primary Liver Cancer (2024 Edition)" or confirmed by histology/cytology.
* Patients with inoperable or metastatic hepatocellular carcinoma.
* No prior systemic therapy for advanced disease. Patients who received adjuvant chemotherapy following local therapy are eligible if chemotherapy was completed \>12 months ago and disease progression or metastasis has occurred.
* Completion of the last interventional therapy, radiotherapy, or ablation therapy \>4 weeks prior.
* For patients with prior hepatectomy, resection must have been R0, and tumor recurrence must have occurred more than 24 months after surgery.
* At least one measurable lesion as defined by RECIST 1.1 criteria.
* Life expectancy ≥3 months.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Child-Pugh score ≤7.
* Able and willing to comply with the protocol for the observation of adverse events and efficacy.
* Adequate organ function, defined as meeting the following criteria:
* Hematological function (without transfusion or granulocyte colony-stimulating factor \[G-CSF\] support within 14 days prior to screening):
* Hemoglobin ≥90 g/L.
* Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L.
* Platelet count ≥75 × 10⁹/L…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
event-free survival
Timeframe: The time from enrollment to the date of first documented progression, recurrence, or death from any cause, whichever came first, assessed up to 36 months
Trial details
NCT IDNCT07584018
SponsorTianjin Medical University Cancer Institute and Hospital