Not yet recruitingNCT07870772Updated Oct 13, 2026

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 interventional study of Intensified Treatment and Continued Treatment in Hepatocellulcar Carcinoma, sponsored by Sun Yat-sen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment

Updated Oct 13, 2026Newly registeredGo to Updates ↓

Phase: Phase 2
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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 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.

Conditions studied

Hepatocellulcar Carcinoma

Keywords

Bevacizumab
Sintilimab
Lenvatinib
PD-1
second-line treatment

In context

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,680 studies on the registry; 609 are open to participants now.

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Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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);
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).

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 100 participants (estimated)

Study arms

Experimental
Intensified Therapy Group
Bevacizumab, PD-1 Inhibitor, Lenvatinib
Drug: Intensified Treatment
Experimental
Continued Therapy Group
Bevacizumab，PD-1 Inhibitor
Drug: Continued Treatment

Interventions

DrugIntensified Treatment
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.
DrugContinued Treatment
Bevacizumab, 15mg/kg, iv drip, q3w; PD-1 inhibitor (Sintilimab, Camrelizumab, Tislelizumab, Toripalimab, Pembrolizumab), 200mg/dose, iv drip, q3w.

What researchers measure

Primary outcomes

Overall Survival (OS)
OS is the length of time from the date of randomization until death from any cause.
Time frame: 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.
Time frame: 6 months

Secondary outcomes

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.
Time frame: 6 months
Adverse Events
Treatment-related or treatment-emergent health problems, including symptoms, laboratory abnormalities, and other medical events occurring during the study.
Time frame: 30 days

Study locations

1 site

Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510000, China

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Jun 2027, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered: Oct 6, 2026
First posted: Oct 13, 2026
StartEst.: Oct 31, 2026
Primary completionEst.: Jun 30, 2027
CompletionEst.: Jul 31, 2027
Last update: Oct 13, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Registered

First appeared on the registry. No changes since

Oct 13, 2026

Show all 1 update

Oct 13, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07870772
Lead sponsor: Sun Yat-sen University
Responsible party: Shi Ming (Professor, Sun Yat-sen University) — Principal investigator
First posted: Oct 13, 2026
Start date: Oct 31, 2026 (estimated)
Primary completion: Jun 30, 2027 (estimated)
Completion: Jul 31, 2027 (estimated)
Last update: Oct 13, 2026

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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