Hepatocellulcar CarcinomaPhase 2NCT07870772
Lenvatinib Plus Bevacizumab and PD-1 Inhibition Versus Bevacizumab Plus PD-1 Inhibition After Progression on Bevacizumab Plus Sintilimab in Unresectable Hepatocellular Carcinoma: A Prospective, Randomized, Two-Cohort, Phase II Study
A Phase 2 study testing Intensified Treatment and Continued Treatment in people with Hepatocellulcar Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
This retrospective study looks at patients with unresectable hepatocellular carcinoma whose cancer progressed after treatment with bevacizumab plus sintilimab. The study compares two treatment approaches used after progression: lenvatinib plus bevacizumab and a PD-1 inhibitor, versus bevacizumab plus a PD-1 inhibitor… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellulcar Carcinoma
- What is being tested?
- Intensified Treatment and Continued Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2026to 31 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with hepatocellular carcinoma (HCC) based on histological or clinical diagnostic criteria;
- Classified as unresectable HCC following multidisciplinary assessment;
- Presence of at least one tumor lesion measurable according to EASL criteria;
- Patients aged ≥18 years and ≤75 years receiving first-line treatment;
- Child-Pugh liver function class A/B, Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0-2;
- Disease progression confirmed by CT/MRI and evaluated according to modified RECIST (mRECIST)/RECIST v1.1 criteria after ≥2 cycles of first-line therapy with bevacizumab (15 mg/kg intravenous infusion, once every 3 weeks) combined with sintilimab (200 mg intravenous infusion, once every 3 weeks);
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- Received ≥2 cycles of post-progression treatment with bevacizumab plus sintilimab, lenvatinib, or regorafenib combined with PD-1 inhibitors;
- Laboratory parameters: hemoglobin(Hb) ≥8.5 g/dL, white blood cell (WBC) count >2000/mm³, platelet (PLT) count ≥75,000/mm³, absolute neutrophil count (ANC) >1500/mm³, total bilirubin ≤30 μmol/L, serum albumin ≥30 g/L, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5 times the upper limit of normal (ULN), serum creatinine ≤1.5 times ULN, international normalized ratio (INR) ≤1.5, prothrombin time (PT) ≤18 seconds;
- Availability of complete baseline data, treatment records, and follow-up data (including imaging assessments, laboratory tests, and clinical documentation).
Who cannot join
- Life expectancy ≤2 months;
- Presence of intrahepatic cholangiocarcinoma, mixed hepatocellular-cholangiocarcinoma, or other non-HCC malignancies;
- Active concurrent malignancy or severe comorbid conditions;
- First-line treatment with other anticancer therapies (chemotherapy, radiotherapy, surgery, or other interventions) concurrently;
- Known hypersensitivity to study drugs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Efficacy and Safety of Lenvatinib Plus Bevacizumab and a PD-1 Inhibitor Versus Bevacizumab Plus a PD-1 Inhibitor After Progression on Bevacizumab Plus Sintilimab in Unresectable Hepatocellular Carcinoma: A Prospective, Randomized, Two-Cohort, Phase II Study
This retrospective study looks at patients with unresectable hepatocellular carcinoma whose cancer progressed after treatment with bevacizumab plus sintilimab.
The study compares two treatment approaches used after progression: lenvatinib plus bevacizumab and a PD-1 inhibitor, versus bevacizumab plus a PD-1 inhibitor alone. We will compare how well these treatments control the cancer, how long patients remain free from disease progression, overall survival, and treatment-related side effects.
Read more
All information will be collected from existing medical records. No additional tests, treatments, or visits are required because of this study. Patient information will be de-identified and kept confidential.
The goal of this study is to better understand whether adding lenvatinib may improve outcomes after bevacizumab plus sintilimab treatment has stopped working, and to provide evidence that may help guide future treatment decisions.
- Conditions
- Hepatocellulcar Carcinoma
- Being tested
- Intensified Treatment, Continued Treatment
- Keywords
- Bevacizumab, Sintilimab, Lenvatinib, PD-1, second-line treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensified TreatmentDrug
Bevacizumab, 15mg/kg, iv drip, q3w; PD-1 Inhibitor, 200mg/dose, iv drip, q3w; Lenvatinib, for weight ≤60 kg, 8 mg/d, po, qd; for weight >60 kg, 12 mg/d, po, qd.
Continued TreatmentDrug
Bevacizumab, 15mg/kg, iv drip, q3w; PD-1 inhibitor (Sintilimab, Camrelizumab, Tislelizumab, Toripalimab, Pembrolizumab), 200mg/dose, iv drip, q3w.
| Study group | Role | What they receive |
|---|---|---|
| Intensified Therapy Group | Experimental | Bevacizumab, PD-1 Inhibitor, Lenvatinib Receives: Drug: Intensified Treatment |
| Continued Therapy Group | Experimental | Bevacizumab，PD-1 Inhibitor Receives: Drug: Continued Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is the length of time from the date of randomization until death from any cause.
Measured: 6 months
Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression or death due to any cause.
Measured: 6 months
Secondary outcomes (2)
Objective Response Rate (ORR)
ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all randomized subjects whose best overall response (BOR) is either a CR or PR.
Measured: 6 months
Adverse Events
Treatment-related or treatment-emergent health problems, including symptoms, laboratory abnormalities, and other medical events occurring during the study.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start31 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellulcar CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Ming, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870772
- Sponsor's protocol ID
- SinBevLen-02
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy and Safety of Lenvatinib Plus Bevacizumab and a PD-1 Inhibitor Versus Bevacizumab Plus a PD-1 Inhibitor After Progression on Bevacizumab Plus Sintilimab in Unresectable Hepatocellular Carcinoma: A Prospective, Randomized, Two-Cohort, Phase II Study
- ClinicalTrials.gov ID
- NCT07870772
- Acronym / sponsor ID
- SinBevLen-02
- Conditions
- Hepatocellulcar Carcinoma
- Keywords
- Bevacizumab, Sintilimab, Lenvatinib, PD-1, second-line treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective study looks at patients with unresectable hepatocellular carcinoma whose cancer progressed after treatment with bevacizumab plus sintilimab.
The study compares two treatment approaches used after progression: lenvatinib plus bevacizumab and a PD-1 inhibitor, versus bevacizumab plus a PD-1 inhibitor alone. We will compare how well these treatments control the cancer, how long patients remain free from disease progression, overall survival, and treatment-related side effects.
All information will be collected from existing medical records. No additional tests, treatments, or visits are required because of this study. Patient information will be de-identified and kept confidential.
The goal of this study is to better understand whether adding lenvatinib may improve outcomes after bevacizumab plus sintilimab treatment has stopped working, and to provide evidence that may help guide future treatment decisions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensified Therapy Group | Experimental | Drug: Intensified TreatmentBevacizumab, PD-1 Inhibitor, Lenvatinib |
| Continued Therapy Group | Experimental | Drug: Continued TreatmentBevacizumab，PD-1 Inhibitor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosed with hepatocellular carcinoma (HCC) based on histological or clinical diagnostic criteria;
- Classified as unresectable HCC following multidisciplinary assessment;
- Presence of at least one tumor lesion measurable according to EASL criteria;
- Patients aged ≥18 years and ≤75 years receiving first-line treatment;
- Child-Pugh liver function class A/B, Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0-2;
Key exclusion criteria (5 listed)
- Life expectancy ≤2 months;
- Presence of intrahepatic cholangiocarcinoma, mixed hepatocellular-cholangiocarcinoma, or other non-HCC malignancies;
- Active concurrent malignancy or severe comorbid conditions;
- First-line treatment with other anticancer therapies (chemotherapy, radiotherapy, surgery, or other interventions) concurrently;
- Known hypersensitivity to study drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensified TreatmentBevacizumab, 15mg/kg, iv drip, q3w; PD-1 Inhibitor, 200mg/dose, iv drip, q3w; Lenvatinib, for weight ≤60 kg, 8 mg/d, po, qd; for weight >60 kg, 12 mg/d, po, qd. | Drug | Intensified Therapy Group |
| Continued TreatmentBevacizumab, 15mg/kg, iv drip, q3w; PD-1 inhibitor (Sintilimab, Camrelizumab, Tislelizumab, Toripalimab, Pembrolizumab), 200mg/dose, iv drip, q3w. | Drug | Continued Therapy Group |
Primary outcome
Overall Survival (OS)
Time frame: 6 months
OS is the length of time from the date of randomization until death from any cause.
Progression Free Survival (PFS)
Time frame: 6 months
PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression or death due to any cause.
2 secondary outcomes
Objective Response Rate (ORR)
Time frame: 6 months
Adverse Events
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intensified Treatment and Continued Treatment in people with Hepatocellulcar Carcinoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.