Lenvatinib mesylate in Hepatocellular Carcinoma: NCT07801287 Clinical Landscape Report 2026

11 September 2026
9 min read

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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.

Data snapshot: 11 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.

Phase 2

Clinical phase

Recruiting

Recruitment status

20

Planned enrollment

2028-08-15

Primary-completion proxy

Executive view

NCT07801287 evaluates Lenvatinib mesylate in Hepatocellular Carcinoma. The disclosed sponsor is Tianjin Medical University Cancer Institute and Hospital, the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is Incidence of TEAEs, assessed over From date of randomization until the occurrence of adverse events assessed up to 24 months.

The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.

PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.

How the MCP evidence stack was assembled

Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07801287 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Hepatocellular Carcinoma landscape. Drug & Asset MCP drug_fetch was queried for Lenvatinib mesylate, while Company & Deal Intelligence MCP organization_fetch was queried for Tianjin Medical University Cancer Institute and Hospital.

This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.

Trial landscape table

TrialAsset / interventionPhase / statusSponsorGeographyPrimary endpointReadout proxy
NCT07801287Lenvatinib mesylatePhase 2 / RecruitingTianjin Medical University Cancer Institute and HospitalChinaIncidence of TEAEs
From date of randomization until the occurrence of adverse events ass…
2028-08-15
NCT07813572BevacizumabPhase 3 / Not yet recruitingSuzhou Zelgen Biopharmaceuticals Co., Ltd.ChinaProgression-free survival (PFS)
up to 3 years
2031-09-01
NCT07806292Anlotinib DihydrochloridePhase 2 / RecruitingSun Yat-Sen Memorial HospitalChinaobjective response rate (ORR)
12 months
2026-12-31
NCT07790419TislelizumabPhase 4 / Not yet recruitingThe First Affiliated Hospital of Zhengzhou UniversityChinaDisease-free survival (DFS)
From the date of randomization until the date of first documented rec…
2028-12-31

The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.

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Protocol design and endpoint interpretation

NCT07801287 is a Phase 2, recruiting study with 20 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.

The primary endpoint is “Incidence of TEAEs” over “From date of randomization until the occurrence of adverse events assessed up to 24 months.” The retrieved endpoint description is: including adverse events and their severity (classified according to CTCAE v5.0), frequency of occurrence, etc..

Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 20 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.

No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.

Indexed readouts in the surrounding landscape

4 recent result records were selected as contextual evidence for Hepatocellular Carcinoma. These records do not establish direct evidence for NCT07801287 unless the registration number matches.

A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475)…

Phase 3; n=480; Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)(Median): Hazard Ratio (HR) = 0.66(95% CI, 0.51 - 0.84), P-Value = 0.0002; Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)(Median): Hazard Rat… Source: https://clinicaltrials.gov/ct2/show/results/NCT04246177

Early Detection, Accurate Staging, and Biologic Characterization of HCC With Hybrid 68Ga-PSMA-Dual -Contrast PET/MRI and PET/CT Using Cyclotron-Produced 68Ga

Phase 2; n=52; High PSMA uptake, grade 3 or 4 = 25 HCC Lesions Source: https://clinicaltrials.gov/ct2/show/results/NCT04762888

Addition of ipilimumab to atezolizumab plus bevacizumab in advanced hepatocellular carcinoma (PRODIGE 81-FFCD 2101-TRIPLET HCC): phase 2 results from a randomised, multicentre, op…

Phase 2/3; n=226; Adverse Event: acute renal failure = 3% of patients in the atezolizumab plus bevacizumab group experienced acute renal failure ; Adverse Event: acute renal failure = 3% of patients in the atezolizumab plus bevacizumab group experienced acute renal failure Source: https://pubmed.ncbi.nlm.nih.gov/42330996/

Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.

Asset and sponsor context

No exact Drug & Asset MCP profile was returned for the protocol wording “Lenvatinib mesylate.” The report therefore avoids inferring modality, target or global development stage from the name alone.

Tianjin Medical University Cancer Institute and Hospital is indexed in China with the website http://www.tjmuch.com. The organization record is used to resolve sponsor identity. The record lists 27 development-stage drug assets.

For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.

Development white space

  1. Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
  2. Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
  3. Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
  4. Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
  5. Sequencing white space. Clarify whether Lenvatinib mesylate is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.

White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.

Strategic implications and next readouts

For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.

For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.

Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.

Source trail and bottom line

Anchor trial: NCT07801287
Protocol source: https://clinicaltrials.gov/study/NCT07801287
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 11 September 2026.

Lenvatinib mesylate in Hepatocellular Carcinoma is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Incidence of TEAEs and 2028-08-15 the leading decision points.

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