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NCT04782804
Adjuvant PD-1 Antibody in Combination With Capecitabine for Patients With ICC at High-Risk of Postoperative Recurrence
Status unknown
Phase 1, PHASE2
Last updated 18 August 2022
What this trial tests
Phase 1, PHASE2 trial testing Capecitabine in Cholangiocarcinoma, Intrahepatic in 30 participants. Status unknown.
Timeline
1 January 2021
Primary endpoint
30 December 2023
30 December 2023
1 May 2024
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 30 |
| Start date | 1 January 2021 |
| Primary completion | 30 December 2023 |
| Estimated completion | 1 May 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Capecitabine (capecitabine) — full drug profile →
- PD-1 Antibody（Tislelizumab） — full drug profile →
Conditions studied
- Cholangiocarcinoma, Intrahepatic — all drugs for Cholangiocarcinoma, Intrahepatic →
Sponsor
Fudan University
Who can join
Adults 18 to 75, any sex, with Cholangiocarcinoma, Intrahepatic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of the study is to observe the effect of PD-1 Antibody（Tislelizumab） Combined With Capecitabine as Adjuvant Therapy to Prevent the Recurrence in High-risk Patients With Cholangiocarcinoma After Curative Resection.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Neoadjuvant and Adjuvant Therapy in Intrahepatic Cholangiocarcinoma.
Chen X, Du J, Huang J, Zeng Y, et al · · 2022 · cited 23× · PMID 35836758 · DOI 10.14218/jcth.2021.00250 -
Current and Emerging Therapeutic Targets for the Treatment of Cholangiocarcinoma: An Updated Review.
Hadfield MJ, DeCarli K, Bash K, Sun G, et al · · 2023 · cited 12× · PMID 38203714 · DOI 10.3390/ijms25010543 -
Severe thyrotoxicosis induced by tislelizumab: a case report and literature review.
Huo L, Wang C, Ding H, Shi X, et al · · 2023 · cited 7× · PMID 37849819 · DOI 10.3389/fonc.2023.1190491 -
Preclinical and clinical studies of immunotherapy for the treatment of cholangiocarcinoma.
Lu X, Green BL, Xie C, Liu C, et al · · 2023 · cited 6× · PMID 37229173 · DOI 10.1016/j.jhepr.2023.100723 -
Management of intrahepatic cholangiocarcinoma: a review for clinicians.
Colangelo M, Di Martino M, Polidoro MA, Forti L, et al · · 2025 · cited 3× · PMID 39867595 · DOI 10.1093/gastro/goaf005 -
Immune-Checkpoint Inhibitors for Biliary Tract Cancer: Who Benefits and What Is Next?
Ceniceros L, Torre M, Landa Magdalena A, Sangro P, et al · · 2025 · cited 1× · PMID 40940908 · DOI 10.3390/cancers17172811 -
Recent advancements in systemic therapy for biliary tract cancers: a literature review.
Hussain MM, Qammar S, Wang JM, Zhai AQ, et al · · 2025 · PMID 41220768 · DOI 10.21037/jgo-2025-83
Verify or expand the search:
- PubMed search for NCT04782804
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Cholangiocarcinoma, Intrahepatic
Currently open trials in the same condition.
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Other Fudan University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04782804 (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: 18 August 2022
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/NCT04782804.
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