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Biliary Tract CancerPhase 2NCT07267078

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

A Phase 2 study testing Tuvonralimab/Iparomlimab combination with GEMOX chemotherapy in people with Biliary Tract Cancer, run by Peking Union Medical College Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Biliary Tract Cancer
What is being tested?
Tuvonralimab/Iparomlimab combination with GEMOX chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteChina
Study dates
25 May 2025to 25 May 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subjects voluntarily participated in the study and agreed to sign the written informed consent. They had good compliance and cooperated well with the follow-up.
  • At the time of signing the informed consent form, the applicant was over 18 years old and could be of any gender.
  • Patients with bile duct cancer diagnosed by histological or imaging methods, and whose imaging assessment or clinical assessment indicates borderline resectability
  • There is at least one measurable lesion (as per the RECIST 1.1 criteria, this measurable lesion must have a spiral CT scan diameter of ≥ 10mm or the short diameter of a swollen lymph node of ≥ 15mm)
  • Patient has not received any systematic treatment in the past
  • The patient has locally advanced disease but no distant metastasis. Theoretically, a R0 resection can be achieved through complex resection combined with vascular reconstruction, but the risk is high.
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  • One of the following situations exists: 1. The main portal vein or a long segment of the hepatic artery on one side is affected, while the other side is still capable of supplying blood or draining. Vascular angioplasty or reconstruction can be performed. 2. The tumor involves the bile duct area beyond one secondary branch, but does not affect the primary branch on the opposite side. It is expected that the available residual liver and bile duct drainage can still be retained. 3. There is suspected regional lymph node metastasis (at the hepatic hilum, abdominal cavity), but there is no distant lymph node or peritoneal implantation.
  • The ECOG score was 0-1 within one week before enrollment.
  • The hematology and organ functions are adequate. Based on the laboratory test results obtained within 14 days prior to the start of the treatment (unless otherwise specified): Blood routine examination: (No blood transfusion, no use of G-CSF, no use of drugs for correction within 14 days before screening): Hb ≥ 90 g/L; Neutrophils ≥ 1.5 × 109/L; PLT ≥ 100 × 109/L. Biochemical examination: (No albumin transfusion within 14 days): Appropriate liver function: ALT and AST ≤ 2.5 × ULN; Bilirubin ≤ 2.0 × upper limit of normal; Appropriate renal function: Creatinine ≤ 1.5 × ULN, or creatinine clearance rate (CCr) > 50 mL/min (using the standard Cockcroft-Gault formula)
  • Fertile women: Agree to abstain from sexual intercourse (avoiding heterosexual intercourse) during the treatment period and for at least 6 months after the last administration (or use a contraceptive method with a failure rate of less than 1% for contraception)
  • Men agree to abstain from sexual intercourse (not having sex with the opposite sex) or to use contraceptive measures, and agree not to donate sperm.

Who cannot join

  • Has previously received any systemic treatment
  • ECOG score > 1 point
  • It is confirmed that there is liver metastasis outside the liver.
  • Pregnant women (with a positive pregnancy test before taking the medicine) or lactating women
  • Those who are known to be allergic to recombinant humanized PD-1 monoclonal antibody drugs, CTLA-4 monoclonal antibody drugs, or their components (or any excipients) are not eligible.
  • Having undergone major surgical procedures (except for biopsy) within 4 weeks prior to the first drug treatment, or having an incomplete healing of the surgical incision
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  • Significant clinical cardiovascular and cerebrovascular diseases, including but not limited to acute myocardial infarction occurring within 6 months prior to enrollment, severe/unstable angina pectoris, cerebrovascular accident or transient cerebral ischemic attack, congestive heart failure (NYHA classification ≥ 2 grade); arrhythmias requiring anti-arrhythmic drug treatment (except for beta-blockers or digoxin); repeated electrocardiogram QTc interval > 480 milliseconds (ms)
  • Impaired liver and kidney functions, including conditions such as jaundice, ascites, and/or bilirubin levels > 3×ULN, creatinine ratio > 3.5g/24 hours, or renal failure requiring blood or peritoneal dialysis. And/or urine routine shows urine protein ≥ ++ or confirmed 24-hour urine protein quantification > 1.0g
  • There is a persistent infection of grade 2 or above (according to CTCAE version 5.0)
  • Having a history of thromboembolic events within the past 6 months (including stroke and/or transient ischemic attack)
  • Hypertension that has not been well controlled by antihypertensive drugs (systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg)
  • Participants who have had active autoimmune diseases or autoimmune disease history in the past two years; those who have active, known, or suspected autoimmune diseases that may affect important organ functions or who already/possibly require systemic immunosuppressive therapy.
  • Known active central nervous system (CNS) metastasis and/or cancerous meningitis
  • Be prepared or have previously undergone organ or allogeneic bone marrow transplantation
  • A known history of active tuberculosis (with the tuberculosis bacteria)
  • Having a history of gastrointestinal bleeding within the past 6 months or having a clear tendency towards gastrointestinal bleeding, and having either a CTCAE 5.0 grade 3 or above gastrointestinal fistula or non-gastrointestinal fistula in the past or currently
  • Known history of human immunodeficiency virus (HIV) infection
  • Those with positive results for active hepatitis B or hepatitis C and who have not received regular treatment. During the screening period, HBV DNA must be ≥ 2000 IU/ml (or ≥ 104 copies/ml). They can be enrolled only after reducing it to < 2000 IU/ml (or < 104 copies/ml) using entecavir; for the enrolled subjects with Anti-HBc(+)/HBsAg (+)/HBV DNA < 2000 IU/ml or Anti-HBc(+)/HBsAg (-)/HBV DNA < 2000 IU/ml, they must receive antiviral treatment during the trial, which can be with the previously used drugs or entecavir or tenofovir.
  • Severe non-healing wounds, ulcers or fractures
  • There is drug abuse; or any medical, psychological or social condition that may affect the research, the patient's compliance, be unstable, or even potentially endanger the patient's safety.
  • There are unresolved toxicities of grade >1 that were caused by any previous treatment/operation (CTCAE 5.0, except for hair loss, anemia, and hypothyroidism)
  • Patients who have objective evidence of severe lung function impairment in the past and at present, such as a history of severe pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, or drug-related pneumonia
  • Received potent CYP3A4 inhibitor treatment within 7 days prior to the study, or received potent CYP3A4 inducer treatment within 12 days prior to the study
  • With other malignant tumors, but having had (within the past 5 years) or concurrently having other untreated malignant tumors, for cured skin basal cell carcinoma, skin squamous cell carcinoma, in situ breast cancer and in situ cervical cancer, treated superficial bladder cancer and prostate adenocarcinoma that underwent surgical treatment and whose PSA tumor marker was within the normal range
  • After the researchers' comprehensive assessment of the patient's condition, it was determined that the patient was not suitable for participating in this study.
  • At the same time, he/she is also participating in another clinical study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Haitao Zhao, 010-69152188, jypeking@163.com

    Recruiting

Other trials in China

About this study

Official title: Neoadjuvant Tuvonralimab and Iparomlimab With Gemcitabine-oxaliplatin for Biliary Tract Cancer

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:

Read more
  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.

Being tested
Tuvonralimab/Iparomlimab combination with GEMOX chemotherapy
Medical subject headings
Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tuvonralimab/Iparomlimab combination with GEMOX chemotherapyDrug

    Tuvonralimab/Iparomlimab combination with GEMOX chemotherapy

Study groups in NCT07267078
Study groupRoleWhat they receive
Tuvonralimab/Iparomlimab combinationExperimentalNot described
Receives: Drug: Tuvonralimab/Iparomlimab combination with GEMOX chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. R0 Resection Rate

    Measured: Baseline (≤28 days before first dose); Neoadjuvant completion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2025
  2. Study start25 May 2025
  3. Primary completion25 Jan 2028 (estimated)
  4. Study completion25 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07267078
Sponsor's protocol ID
QLIT-BTC
Status last verified
Sep 2025
First submitted
24 Nov 2025
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Feng Bi et al. First-line iparomlimab and tuvonralimab (QL1706) or iparomlimab (QL1604) + bevacizumab (BEV) for unresectable hepatocellular carcinoma (HCC): Updated results from the phase Ib/II DUBHE-H-106 study.. JCO 43, 579-579(2025).

  • Zhang Y, Huang Y, Yang Y, Zhao Y, Zhao H, Zhou N, Chen L, Zhou T, Chen G, Zhao S, Zhou H, Li H, Kang X, Zhang L, Fang W. Iparomlimab and tuvonralimab (QL1706) plus chemotherapy and bevacizumab for EGFR-mutant patients with advanced non-small cell lung cancer after failure of EGFR-tyrosine kinase inhibitors: updated results from cohort 5 in the DUBHE-L-201 study. J Hematol Oncol. 2025 Jul 26;18(1):75. doi: 10.1186/s13045-025-01728-9.

    PubMed 40713827

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tuvonralimab/Iparomlimab combination with GEMOX chemotherapy in people with Biliary Tract Cancer, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 Resection Rate (time frame: Baseline (≤28 days before first dose); Neoadjuvant completion.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07267078, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.

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