Hepatocellular Carcinoma (HCC)CHANCE2602NCT07836309
TACE in Combination With Tislelizumab and Lenvatinib for Advanced HCC (CHANCE2602)
An observational study of Hepatocellular Carcinoma (HCC), run by Zhongda Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with Tislelizumab and Lenvatinib in patients with advanced-stage hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- How many people
- 596 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2026to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with advanced HCC who received Tislelizumab and Lenvatinib with/without TACE under real-world practice conditions.
Who may be able to join
- Histologically or cytologically confirmed hepatocellular carcinoma (HCC), or patients who meet the clinical diagnostic criteria for primary liver cancer;
- Age ≥18 years at the time of HCC diagnosis;
- Barcelona Clinic Liver Cancer (BCLC) stage C;
- No prior systemic therapy for HCC (including chemotherapy, molecular targeted therapy, or immunotherapy);
- Received treatment with tislelizumab and lenvatinib, with the interval between the first administration of the two drugs ≤1 week;
- In the experimental group, TACE was performed within 3 months before or after treatment with tislelizumab and lenvatinib;
Show all 10Show fewer
- After TACE, patients received at least one cycle of combination therapy with tislelizumab and lenvatinib, including cTACE and DEB-TACE;
- Child-Pugh class A5 to B7;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1;
- At least one measurable intrahepatic lesion according to RECIST 1.1 criteria.
Who cannot join
- Known fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular-cholangiocarcinoma histological types;
- Complete obstruction of the main portal vein with insufficient collateral compensation;
- Uncontrollable ascites or hepatic encephalopathy;
- Incomplete clinical data or missing essential information;
- Presence of other primary malignant tumors in addition to the diagnosis of liver cancer;
- Participation in other interventional studies prior to treatment;
- Other conditions deemed unsuitable for inclusion by the investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongda Hospital, School of Medicine, Southeast University
Nanjing, Jiangsu, 210009
Zhicheng Jin
+86-025-83272121
About this study
Official title: Efficacy and Safety of Transarterial Chemoembolization in Combination With Tislelizumab and Lenvatinib for Advanced Stage HCC (CHANCE2602)
The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with Tislelizumab and Lenvatinib in patients with advanced-stage hepatocellular carcinoma (HCC).
Read the detailed description
Transarterial chemoembolization (TACE) can induce immunogenic cell death and tumor-specific immune response which results in the release of tumor antigens and transform "cold" tumors with lacking immune effector cells into "hot" tumors with immune effector cells infiltration. This provides a theoretical basis for TACE combined with immune checkpoint inhibitors (ICIs) in hepatocellular carcinoma (HCC) patients. Tislelizumab is a PD-1 monoclonal antibody approved by the National Medical Products Administration (NMPA) of China for first-line and second-line treatment of patients with HCC. The purpose of this real-world study is to evaluate the safety and efficacy of TACE in combination with Tislelizumab and Lenvatinib in patients with advanced-stage HCC.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- TACE, Tislelizumab, Lenvatinib, HCC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | TACE + Tislelizumab + Lenvatinib TACE was performed within 3 months before or after the first Tislelizumab /Lenvatinib treatment. The interval between first use Tislelizumab and Lenvatinib ≤1 week； | |
| Control group | Tislelizumab + Lenvatinib The interval between first use Tislelizumab and Lenvatinib ≤1 week； |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival(OS)
The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
Measured: up to approximately 2 years
Secondary outcomes (9)
Progression free survival(PFS) per RECIST 1.1
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST 1.1) or death due to any cause, whichever occurs first.
Measured: up to approximately 2 years
PFS per mRECIST
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first.
Measured: up to approximately 2 years
Objective response rate(ORR) per RESCIST 1.1
The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.
Measured: up to approximately 2 years
Duration of Response (DOR) per RESCIST 1.1
DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression (according to RESCIST 1.1) or death due to any cause, whichever occurs first.
Measured: up to approximately 2 years
Disease Control Rate (DCR) per RESCIST 1.1
DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD)per RESCIST 1.1.
Measured: up to approximately 2 years
ORR per mRECIST
The ORR is defined as the proportion of patients with a documented CR or PR per mRECIST.
Measured: up to approximately 2 years
DOR per mRECIST
DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression (according to mRECIST) or death due to any cause, whichever occurs first.
Measured: up to approximately 2 years
DCR per mRECIST
DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD) per mRECIST.
Measured: up to approximately 2 years
Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0
The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0.
Measured: up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 596 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836309
- Sponsor's protocol ID
- CHANCE2602
- Acronym
- CHANCE2602
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No