Cancer cocktail aims to turn inoperable tumors into surgical wins
NCT ID NCT07263360
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether a mix of immunotherapy (iparomlimab and tuvonralimab), chemotherapy (gemcitabine and oxaliplatin), and a targeted drug (lenvatinib) can shrink bile duct and gallbladder cancers enough to be surgically removed. About 29 adults with locally advanced but potentially resectable cancer will receive up to six cycles of treatment. The main goal is to see how many patients can have complete tumor removal (R0 resection).
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Iparomlimab and Tuvonralimab (immunotherapy) combined with Gemcitabine, Oxaliplatin, and Lenvatinib (chemotherapy and targeted therapy)
- What this could lead to
- If successful, this combination could shrink tumors enough to allow surgical removal, potentially improving long-term survival for people with bile duct or gallbladder cancer.
- What could go wrong
- This is a small, early-phase trial with only 29 participants, so results may not apply to everyone. The combination of drugs can cause significant side effects, and it is not yet known if it will work better than standard treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 29 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years, male or female. * Histologically or cytologically confirmed diagnosis of locally advanced or potentially resectable intrahepatic cholangiocarcinoma or gallbladder cancer, defined as T2b-T4 or N1 M0 according to the AJCC 8th edition. * Expected life expectancy ≥ 12 weeks. * No prior systemic treatment for biliary tract cancer before the first dose of study medication. * At least one measurable lesion as defined by RECIST 1.1 criteria. * ECOG Performance Status of 0 or 1. * Adequate organ function, without severe dysfunction of the hematologic, cardiac, pulmonary, hepatic, renal, bone marrow, or immune systems. * Laboratory tests meeting the following requirements: Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days before enrollment and voluntarily use adequate contraception during the observation period and for 8 weeks after the last dose of the study drug. For men, they must be surgically sterile or agree to use adequate contraception during the observation period and for 8 weeks after the last dose of the study drug. * Patient voluntarily participates and provides written informed consent. * Good compliance is anticipated, allowing for efficacy and adverse event follow-up per the protocol. Exclusion Criteria: * The subject has received any prior antitumor therapy or any investigational anticancer agents. * Presence of any active autoimmune disease or a history of autoimmune diseases (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism \[may be enrolled if stable on hormone replacement therapy\]). Patients with childhood asthma that has completely resolved in adulthood without any intervention, or vitiligo, may be enrolled. Patients requiring medical intervention with bronchodilators are not eligible. * Known congenital or acquired immunodeficiency, such as Human Immunodeficiency Virus (HIV) infection. * Uncontrolled cardiac clinical symptoms or diseases, e.g., NYHA Class II or above heart failure, unstable angina, myocardial infarction within 1 year, or patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention. * Severe concurrent infection within 4 weeks prior to the first dose (e.g., requiring intravenous antibiotics, antifungals, or antivirals), or unexplained fever \>38.5°C during screening/prior to the first dose. * Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. * Administration of a live attenuated vaccine within 4 weeks prior to the first dose or planned administration during the study period. * History of or concurrent other malignant tumors within the past 5 years (except for adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, and ovarian cancer). * Gastrointestinal bleeding event or active hemoptysis within 28 days prior to the first dose. * Gastric or esophageal varices requiring treatment. * Active malignant tumors within 36 months prior to enrollment. * Known allergy to any of the investigational drug components. * Poorly controlled psychiatric disorder. * Presence of superior mesenteric vein tumor thrombus, metastasis to group 16 lymph nodes, or distant metastasis to other organs / biological factors: peritoneal metastasis, direct invasion to adjacent organs, etc. / involvement of organs (pancreas, stomach, duodenum, colon) that cannot be resected en bloc. * Any other condition deemed by the investigator as unsuitable for enrollment. This includes, but is not limited to, pre-existing central nervous system metastases, severe laboratory abnormalities, or familial/social factors that could compromise the subject's safety, or data/sample collection. * Patients with extensive liver metastases involving the entire liver.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a simple score spot hidden gallbladder cancer?
- Can Re-Assessing bile duct cancer treatment open the door to surgery?
- Radiation beads plus immunotherapy: a new way to attack liver cancer?
- Can an immunotherapy combo turn inoperable gallbladder cancer into a surgical success?
- Can sound waves supercharge immunotherapy against bile duct cancer?
- Can blood tests reveal how liver and bile duct cancers respond to treatment?