RecruitingPhase 2interventionalRules rewrite

Phase 2: testing sintilimab for Hepato Cellular Carcinoma (HCC)

Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related mortality worldwide. The recurrence rate after curative resection for early-stage HCC remains extremely high, with 2-year and 5-year recurrence rates reaching 50% and 70%, respectively.

Official registry: https://clinicaltrials.gov/study/NCT07487662 · Sun Yat-sen University · enrollment listed as 105

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are sintilimab, ipilimumab N01, or Lenvatinib. The registry lists allocation as randomized. Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related mortality worldwide.

They plan to enroll about 105 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.

Official title (unrewritten)

TACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With Intermediate-High Recurrence Risk: A Multicenter, Multigroup, Randomized, Phase Ⅱ Exploratory Clinical Trial

Interventions: sintilimab, ipilimumab N01, Lenvatinib, TACE, ablation

Primary outcome (registry wording): 1-year recurrence-free survival rate

Who it is for (from inclusion criteria)

Ages 18 Years to 75 Years
1\) Age: 18-75 years old; 2) Patients with hepatocellular carcinoma (HCC) classified as CNLC stage Ib-IIIa (excluding patients with Vp3 and Vp4), and deemed resectable by multidisciplinary team (MDT) discussion;
3\) No prior tumor-related treatment received;
4\) At least one measurable target lesion according to the RECIST 1.1 criteria;
5\) ECOG PS score of 0-1;
6\) Liver function classification: Child-Pugh Class A;
7\) Estimated survival time ≥ 12 weeks;
8\) Hematological, liver, and renal functions meet the following criteria:

Who the registry excludes

1\) Prior history of HCC treatment; 2) Tumor rupture and bleeding, or suspected peritoneal metastasis;
3\) History of other complex surgeries within 6 weeks;
4\) Prior history of organ transplantation;
5\) Currently receiving treatment in other clinical trials;
7\) Prior history of allergy to anti-PD1 drugs, TKI or anti-CTLA4 drugs, or allergy to chemical molecules similar to the above drugs, or prior severe allergic reaction to other monoclonal antibodies;
9\) Patients with prior hepatic encephalopathy, refractory ascites, or esophagogastric varices with high bleeding risk; patients with upper gastrointestinal bleeding within 1 year before the first administration;
11\) Patients with primary brain tumors (except meningiomas or other benign brain tumors), or any brain metastases, leptomeningeal carcinomatosis, epilepsy uncontrollable by conventional drugs, or new-onset stroke within 1 year;

Public study contact (from the registry)

Ming Kuang

+86 020-87755766

kuangm@mail.sysu.edu.cn

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (recruiting)

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FAQ about this NCT record

Is NCT07487662 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07487662?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07487662?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary