Evidence map›Paper›PMID 40625746›Full record

Trial reportFrontiers in immunology2025

Matching-adjusted indirect comparison of tislelizumab plus lenvatinib versus sintilimab plus bevacizumab biosimilar as first-line treatment for unresectable hepatocellular carcinoma.

Kunyuan Wang, Chang Liu, Xiaoling Song, Na Zhao, Xin Zheng

2 registry-linked trialsAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIComparative Study
In one paragraph

Trial report in Frontiers in immunology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03794440 phase2 / phase3unknown statusnot on this map

A Randomized, Open-label,Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Sintilimab and IBI305 Compared to Sorafenib in the First-Line Treatment of Patients With Advanced Hepatocellular Carcinoma. (ORIENT-32)

TypeinterventionalSponsorInnovent Biologics (Suzhou) Co. Ltd.Ran2019 to 2022Enrolled595ConditionsHepatocellular CarcinomaArmsSintilimab, IBI305, Sorafenib
NCT04401800 phase2completednot on this map

A Phase 2 Study to Investigate the Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib in Patients With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma

TypeinterventionalSponsorBeiGeneRan2020 to 2024Enrolled64ConditionsHepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma, Metastatic Hepatocellular CarcinomaArmsLenvatinib, Tislelizumab
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Kunyuan Wang *Department of Infectious Diseases and Hepatology, State Key Laboratory of Organ Failure Research, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Chang Liu *Division of Abdominal Tumor Multimodality Treatment, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.
Xiaoling Song *Department of General Surgery and Laboratory of General Surgery, Shanghai Key Laboratory of Biliary Tract Disease Research, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Na ZhaoGlobal Statistics and Data Science, BeiGene (Shanghai) Co., Ltd., Shanghai, China.
Xin ZhengDepartment of Hepatobiliary Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Programmed cell death-1/programmed cell death-ligand 1 (PD-[L]1) inhibitors plus bevacizumab (or biosimilars) or tyrosine kinase inhibitors (TKIs) have been widely used for the first-line treatment of patients with unresectable hepatocellular carcinoma (uHCC). However, no head-to-head trials have compared the efficacy outcomes between these two combination regimens. Therefore, an unanchored matching-adjusted indirect comparison (MAIC) was conducted to evaluate the comparative efficacy of tislelizumab plus lenvatinib versus sintilimab plus bevacizumab biosimilar. Methods: Individual patients from the BGB-A317-211 study (NCT04401800) for tislelizumab plus lenvatinib were adjusted to match the population from the ORIENT-32 (NCT03794440) for sintilimab plus bevacizumab biosimilar through an unanchored MAIC. Odds Ratios (ORs) of objective response rates (ORR) and disease control rates (DCR), and hazard ratios (HRs) of progression-free survival (PFS) and overall survival (OS) were evaluated to quantify the relative treatment effect between the two treatment regimens after population matching. Sensitivity analyses were performed by sequentially removing one variable in the matching and adjusting the population through simulated treatment comparison (STC). Results: After matching, baseline characteristics were balanced between the tislelizumab plus lenvatinib group (effective sample size [ESS] = 49, ESS/N = 79.03%) and sintilimab plus bevacizumab biosimilar group (N = 380). MAIC analysis indicated that tislelizumab plus lenvatinib group showed significantly higher ORR per RECIST v1.1 (OR = 2.56, 95% CI 1.40-4.63; Conclusions: This MAIC analysis demonstrated that tislelizumab plus lenvatinib achieved superior efficacy, with higher ORR and longer PFS and OS compared to sintilimab plus bevacizumab biosimilar in untreated Chinese patients with uHCC.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBiosimilar PharmaceuticalsCarcinoma, HepatocellularLiver NeoplasmsPhenylurea CompoundsQuinolinesAdultAgedFemaleHumansMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedBevacizumabBiosimilar PharmaceuticalslenvatinibPhenylurea CompoundsQuinolinessintilimabtislelizumabbevacizumabhepatocellular carcinomalenvatinibmatching-adjusted indirect comparisonsintilimabtislelizumab

Identifiers

PMID40625746
PMCPMC12230042

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.