Sintilimab in Hepatocellular Carcinoma: NCT07761286 Clinical Landscape Report 2026
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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: 16 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 1/2
Clinical phase
Not yet recruiting
Recruitment status
288
Planned enrollment
2029-09-30
Primary-completion proxy
Executive view
NCT07761286 evaluates Sintilimab in Hepatocellular Carcinoma. The disclosed sponsor is CSPC Megalith Biopharmaceutial Co., Ltd., the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs), assessed over Up to 2 years..
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 NCT07761286 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 Sintilimab, while Company & Deal Intelligence MCP organization_fetch was queried for CSPC Megalith Biopharmaceutial Co., Ltd..
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
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT07761286 | Sintilimab | Phase 1/2 / Not yet recruiting | CSPC Megalith Biopharmaceutial Co., Ltd. | China | Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) Up to 2 years. | 2029-09-30 |
| NCT07749859 | Apatinib Mesylate | Phase 2 / Not yet recruiting | Cancer Hospital Chinese Academy of Medical Sciences | China | Objective Response Rate (ORR) From first dose until disease progression, death, or 24 months, which… | 2028-07-01 |
| NCT07746960 | Anlotinib Dihydrochloride | Early Phase 1 / Active, not recruiting | Nanfang Hospital | China | ORR through study completion.Continuously follow up the patient's subsequ… | 2026-10-31 |
| NCT07738055 | Envafolimab | Not Applicable / Not yet recruiting | Tianjin Medical University Cancer Institute and Hospital | Geography not reported | Surgical conversion rate The conversion rate for the first to third cycles of medication (each… | 2029-01-31 |
| NCT07734766 | Ebastine | Phase 4 / Not yet recruiting | The Second Affiliated Hospital of Xi'An Jiaotong University | Geography not reported | 1-Year Recurrence-Free Survival (RFS) Rate 1 year after surgery | 2029-03-01 |
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
NCT07761286 is a Phase 1/2, not yet recruiting study with 288 planned participants. Allocation is Randomized, masking is None (Open Label), and the intervention model is Factorial Assignment.
The primary endpoint is “Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)” over “Up to 2 years..” The retrieved endpoint description is: Evaluated incidence and severity of all Adverse Events (AEs) and Serious Adverse Events (SAEs) graded per NCI-CTCAE version 6.0, including abnormal laboratory tests, ECG parameters and vital signs from screening through end of safety follow-up..
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 288 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 NCT07761286 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.libproxy1.nus.edu.sg/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
Sintilimab is indexed as Monoclonal antibody with PD-1 biology and a global stage of Approved. The asset profile lists Eli Lilly & Co. as an originator or developer.
CSPC Megalith Biopharmaceutial Co., Ltd. is indexed in China with the website http://www.e-cspc.com. The organization record is used to resolve sponsor identity. The record lists 45 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
- 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.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Sintilimab 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: NCT07761286
Protocol source: https://clinicaltrials.gov/study/NCT07761286
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: 16 September 2026.
Sintilimab 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 Adverse Events (AEs) and Serious Adverse Events (SAEs) and 2029-09-30 the leading decision points.
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