NCT07267078

Tuvonralimab and Iparomlimab Based Regimens for the Neoadjuvant Treatment of Biliary Tract Cancer

Recruiting now Phase 2 Last updated 5 December 2025

What this trial tests

Phase 2 trial testing Tuvonralimab/Iparomlimab combination with GEMOX chemotherapy in Biliary Tract Cancer in 45 participants. Currently enrolling.

Timeline

25 May 2025

Primary endpoint
25 January 2028

25 May 2028

Quick facts

Lead sponsor	Peking Union Medical College Hospital
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	25 May 2025
Primary completion	25 January 2028
Estimated completion	25 May 2028
Sites	1 location across China

Drugs / interventions tested

• Tuvonralimab/Iparomlimab combination with GEMOX chemotherapy — full drug profile →

Conditions studied

• Biliary Tract Cancer — all drugs for Biliary Tract Cancer →

Sponsor

Peking Union Medical College Hospital

Who can join

Adults 18 to 75, any sex, with Biliary Tract Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to learn if Tuvonralimab/Iparomlimab-based neoadjuvant regimens can improve surgical and pathological outcomes in adults (≥18 years) with resectable or borderline-resectable biliary tract cancer (intrahepatic/extrahepatic cholangiocarcinoma or gallbladder cancer), ECOG 0-1, and no prior neoadjuvant therapy.

The main questions it aims to answer are:

1. Does the regimen increase the R0 resection rate (negative margins)?
2. Does it raise major or pathologic complete response rates (MPR/pCR) and improve event-free survival (EFS) without increasing perioperative complications?

Researchers will compare Tuvonralimab/Iparomlimab-based therapy + GEMOX chemotherapy to surgery to see if immunotherapy leads to higher R0 resection, deeper pathologic response, and better EFS/PFS/OS with acceptable safety.

Participants will:

Undergo baseline assessments: imaging (contrast-enhanced CT/MRI ± PET), labs, histology, and optional biomarker sampling.

Receive neoadjuvant therapy: 2-4 cycles (\\\~6-12 weeks) of a Tuvonralimab/Iparomlimab-based regimen per protocol.

Have restaging by RECIST 1.1; eligible participants proceed to curative-intent surgery with central review of margins and tumor regression grading (TRG/MPR/pCR).

Receive protocol-directed postoperative management and safety monitoring (CTCAE v5.0) and be followed every 8-12 weeks for EFS, PFS, OS, conversion-to-resection rate, nodal down-staging, perioperative complications, length of stay, and any surgery delays.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.