NCT05430698

PD-1 Antibody Plus GEMOX as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma

Recruiting now Phase 2 Last updated 9 February 2026

What this trial tests

Phase 2 trial testing PD-1antibody plus GEMOX in Perihilar Cholangiocarcinoma in 62 participants. Currently enrolling.

Timeline

31 January 2023

Primary endpoint
31 January 2027

31 December 2027

Quick facts

Lead sponsor	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	62
Start date	31 January 2023
Primary completion	31 January 2027
Estimated completion	31 December 2027
Sites	1 location across China

Drugs / interventions tested

• PD-1antibody plus GEMOX — full drug profile →

Conditions studied

• Perihilar Cholangiocarcinoma — all drugs for Perihilar Cholangiocarcinoma →

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Who can join

Adults 18 to 75, any sex, with Perihilar Cholangiocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label,single center,non-randomized,single arm exploratory study. The objective of this study is to evaluate the efficacy and safety of PD-1 antibody plus GEMOX as postoperative adjuvant therapy in perihilar cholangiocarcinoma with positively metastatic lymph nodes.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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
2. 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