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New treatment option for Biliary Tract Cancer
Official title Tuvonralimab and Iparomlimab Based Regimens for the Neoadjuvant Treatment of Biliary Tract Cancer
ClinicalTrials.gov ID: NCT07267078
What this study is testing
What is Tuvonralimab/Iparomlimab combination with GEMOX chemotherapy?
Tuvonralimab/Iparomlimab combination with GEMOX chemotherapy is an investigational medicine, being studied as a potential treatment for biliary tract cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- The people voluntarily participated in the study and agreed to sign the written informed consent. They had good compliance and cooperated well with...
- 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...
- 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...
- Patient has not received any systematic treatment in the past
You likely can't join if
- 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...
- Having undergone major surgical procedures (except for biopsy) within 4 weeks prior to the first drug treatment, or having an incomplete healing of...
See the full eligibility criteria
Who can join
- The people 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.
- 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...
- 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...
- 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...
- 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.
What rules you out
- 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
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.