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NCT05781074: CASTLE-08
Cryoablation Combined With Sintilimab Plus Lenvatinib in Patients With Immune Checkpoint Inhibitor Previously Treated Advanced Biliary Tract Cancer （CASTLE-08）
Phase 2 trial testing Sintilimab in Advanced Biliary Tract Cancer in 25 participants. Status unknown.
30 December 2025
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 23 March 2023 |
| Primary completion | 30 December 2025 |
| Estimated completion | 30 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Sintilimab — full drug profile →
- Lenvatinib (LENVATINIB) — full drug profile →
- Cryoablation — full drug profile →
Conditions studied
- Advanced Biliary Tract Cancer — all drugs for Advanced Biliary Tract Cancer →
Sponsor
Fudan University
Who can join
18 and older, any sex, with Advanced Biliary Tract Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this study is to evaluate the efficacy and safety of cryoablation combined with Sintilimab plus lenvatinib in patients with Immune Checkpoint Inhibitor previously treated advanced biliary tract cancer (BTC).
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Modern cancer therapy: cryoablation meets immune checkpoint blockade.
Liu Q, Zhang C, Chen X, Han Z. · · 2024 · cited 12× · PMID 38384806 · DOI 10.3389/fonc.2024.1323070 -
Recent Advances in Immunotherapy for Advanced Biliary Tract Cancer.
Yue S, Zhang Y, Zhang W. · · 2024 · cited 11× · PMID 39066855 · DOI 10.1007/s11864-024-01243-y -
Contribution of immune cells in synergistic anti-tumor effect of ablation and immunotherapy.
He N, Jiang J. · · 2024 · cited 8× · PMID 38070356 · DOI 10.1016/j.tranon.2023.101859 -
Interventional oncology and immunotherapy: current status and future perspectives.
Ma J, Wei Z, Ye X. · · 2025 · PMID 40264767 · DOI 10.3389/fimmu.2025.1541105
Verify or expand the search:
- PubMed search for NCT05781074
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07537972 — Denosumab Strategy for Liver Cancer With Bone Metastases · Phase 2 · not yet recruiting
- NCT07468630 — Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma · Phase 2 · recruiting
- NCT07515625 — Efficacy of Sintilimab Combined With Bevacizumab and XELOX/SOX in Initially Unresectable AFP-positive Gastric/Gastroesop · Phase 2 · not yet recruiting
Other recruiting trials for Advanced Biliary Tract Cancer
Currently open trials in the same condition.
- NCT06988592 — GemCis Plus PD-1/PD-L1 Inhibitor in Advanced Biliary Tract Cancer: Efficacy and Immune Microenvironment （BTC-IM-1） · recruiting
- NCT04969887 — Combination Immunotherapy in Rare Cancers Under InvesTigation · Phase 2 · active not recruiting
- NCT04727996 — Phase II Study of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Biliary Tract Cancer · Phase 2 · active not recruiting
- NCT04005339 — NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer · Phase 2 · active not recruiting
Other Fudan University trials
Trials by the same sponsor.
- NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
- NCT07423611 — ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer · Phase 2 · not yet recruiting
- NCT07410559 — Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Bre · Phase 2 · not yet recruiting
- NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
- NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · Phase 2 · not yet 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 NCT05781074 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fudan University
- Last refreshed: 24 March 2023
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/NCT05781074.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing