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NCT07310836
A Retrospective Study of Safety and Efficacy of Locoregional Therapies Combined With Anti-VEGF/TKIs and Immune Checkpoint Inhibitors for All Comers of Intention-to-treat Patients With Hepatocellular Carcinoma Beyond UCSF Criteria Before Liver Transplantation
trial testing Locoregional Therapy (LRT) + Systemic Drug Therapy in Hepatocellular Carcinoma in 300 participants. Not yet recruiting.
31 December 2025
Quick facts
| Lead sponsor | Ningbo Medical Center Lihuili Hospital |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 20 December 2025 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 March 2026 |
Drugs / interventions tested
- Locoregional Therapy (LRT) + Systemic Drug Therapy
Conditions studied
- Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →
- Liver Transplantation — all drugs for Liver Transplantation →
Sponsor
Ningbo Medical Center Lihuili Hospital
Who can join
16 and older, any sex, with Hepatocellular Carcinoma or Liver Transplantation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a single-center, retrospective cohort study aiming to evaluate the safety and efficacy of a combined treatment strategy for patients with hepatocellular carcinoma (HCC) who are beyond the UCSF criteria but intended for liver transplantation. The primary objective is to assess the outcomes of these "intention-to-treat" patients who received locoregional therapies (LRT, such as TACE or radiotherapy) in combination with systemic therapy (anti-VEGF/Tyrosine Kinase Inhibitors and Immune Checkpoint Inhibitors) as a "conversion therapy" prior to potential transplantation. This approach is distinct from traditional bridging or down-staging therapies by incorporating more aggressive systemic regimens. The study plans to enroll 300 subjects. The exposure group will include approximately 100 patients beyond UCSF criteria who received the combined conversion therapy between January 2020 and December 2024. A control group of about 200 patients who met the UCSF criteria and were directly listed for transplantation in the same period will be used for comparison. Data will be collected from medical records and the China Liver Transplant Registry (CLTR), with follow-up until December 2025. Primary outcome measures include: Objective Response Rate (ORR) of conversion therapy per mRECIST. Rate of successful down-staging to meet UCSF criteria. 1-, 2-, and 3-year overall survival (OS) rates of the intention-to-treat population. Actual liver transplantation rate after successful conversion. Post-transplant 1-, 2-, and 3-year OS and recurrence-free survival (RFS) rates. Secondary outcomes involve: Safety profiles of both conversion therapy and subsequent transplantation. Analysis of factors influencing conversion success and treatment efficacy. Determination of an optimal washout period for Immune Checkpoint Inhibitors prior to transplantation. The study seeks to provide high-level evidence for optimizing pre-transplant conversion strategies for advanced HCC patients currently outside standard transplant criteria.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07310836
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Locoregional Therapy (LRT) + Systemic Drug Therapy
Trials testing the same drug.
- NCT07368023 — A Retrospective Study of Safety and Efficacy of Locoregional Therapies Combined With Anti-VEGF/TKIs and Immune Checkpoin · not yet recruiting
Other recruiting trials for Hepatocellular Carcinoma
Currently open trials in the same condition.
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- NCT07417397 — Adjuvant TACE in HCC With High-risk Recurrence Factors · Phase 3 · recruiting
- NCT07317414 — β-alanine in the Treatment of Advanced Hepatocellular Carcinoma · Phase 2 · recruiting
- NCT07148050 — Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimer · Phase 1 · recruiting
Other Ningbo Medical Center Lihuili Hospital trials
Trials by the same sponsor.
- NCT07572708 — Transcutaneous Electrical Acustimulation (TEA) for the Treatment of Non-Erosive Gastroesophageal Reflux Disease (NERD) · NA · not yet recruiting
- NCT07368023 — A Retrospective Study of Safety and Efficacy of Locoregional Therapies Combined With Anti-VEGF/TKIs and Immune Checkpoin · not yet recruiting
- NCT07273032 — Clinical Application Research of Combined Therapy in ERAS for Accelerated Orthopedic Rehabilitation · Phase 4 · not yet recruiting
- NCT06982664 — Effect of Preserving the Left Colic Artery on Proximal Bowel Perfusion · NA · not yet recruiting
- NCT06804733 — Efficacy of Individualized Aerobic Exercise Training in Patients With Inflammatory Bowel Disease · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07310836 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ningbo Medical Center Lihuili Hospital
- Last refreshed: 30 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07310836.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing