BridgeMD
New treatment option for Cholangiocarcinoma
Official title PULSAR Combined With Immunotherapy and Chemotherapy
ClinicalTrials.gov ID: NCT07291947
What this study is testing
What is Iparomlimab and Tuvonralimab Injection (QL1706)?
Iparomlimab and Tuvonralimab Injection (QL1706) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cholangiocarcinoma.
Also referred to as chemotherapy.
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 primary objective of this study is to evaluate the efficacy and safety of PULSAR in combination with dual immune checkpoint inhibitors (PD-1 monoclonal antibody + CTLA-4 monoclonal antibody) and GC chemotherapy in patients with locally advanced or metastatic cholangiocarcinoma. The secondary objective of this study is to investigate the immunological impact of PULSAR combined with dual immune therapy (PD-1 monoclonal antibody + CTLA-4 monoclonal antibody) on the tumor microenvironment and systemic immune responses in cholangiocarcinoma patients.
- 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
- Signed informed consent. The subject has fully understood and accepted the purpose, content, expected how well it works, mechanism of action, and...
- Age 18-75 years, regardless of gender.
- Histopathologically or cytologically confirmed locally advanced or metastatic cholangiocarcinoma.
- At least one measurable lesion based on RECIST 1.1 criteria.
- ECOG performance status score of 0-1.
You likely can't join if
- Previously treated with anti-PD-1 or anti-PD-L1 antibodies.
- Received any investigational drug treatment within 4 weeks prior to the first administration of the study drug.
- Simultaneous participation in other clinical studies, unless it is an observational (non-treatment) clinical study or the follow-up phase of an...
- Previously received radiotherapy to the upper abdomen.
- Uncontrolled severe diseases that the investigator considers may affect the subject's ability to receive study protocol treatment, such as severe...
- Active known or suspected autoimmune diseases (including but not limited to uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis...
See the full eligibility criteria
- Signed informed consent. The subject has fully understood and accepted the purpose, content, expected how well it works, mechanism of action, and risks of the study, and has signed the informed consent form.
- Age 18-75 years, regardless of gender.
- Histopathologically or cytologically confirmed locally advanced or metastatic cholangiocarcinoma.
- At least one measurable lesion based on RECIST 1.1 criteria.
- ECOG performance status score of 0-1.
- Expected survival time ≥3 months.
- Willing to comply with study procedures and able to undergo treatment (including radiotherapy, immunotherapy, chemotherapy) and follow-up.
- No contraindications to the use of PD-1, PD-L1 inhibitors, gemcitabine, or cisplatin.
- No contraindications to radiotherapy.
- Organ function levels meet the following requirements: - Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; - Platelet (PLT) count ≥ 80 × 10⁹/L; - Hemoglobin (Hb) level ≥ 90 g/L; - Total bilirubin (TBil) level ≤ 1.5 times...
- Women of childbearing potential must agree to use appropriate contraceptive measures during the study period. Additionally, a serum or urine pregnancy test performed within 24 hours prior to the initiation of...
- Women must be non-lactating.
- Previously treated with anti-PD-1 or anti-PD-L1 antibodies.
- Received any investigational drug treatment within 4 weeks prior to the first administration of the study drug.
- Simultaneous participation in other clinical studies, unless it is an observational (non-treatment) clinical study or the follow-up phase of an treatment clinical study.
- Previously received radiotherapy to the upper abdomen.
- Uncontrolled severe diseases that the investigator considers may affect the subject's ability to receive study protocol treatment, such as severe cardiac disease, cerebrovascular disease, uncontrolled diabetes...
- Active known or suspected autoimmune diseases (including but not limited to uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilator...
- Active tuberculosis infection. Patients with active pulmonary tuberculosis infection within the past year will be excluded, even if treated. Patients with a history of active pulmonary tuberculosis infection more than...
- Patients requiring long-term systemic corticosteroid therapy (equivalent to \>10 mg prednisone/day) or any other form of immunosuppressive therapy. Patients using inhaled or topical corticosteroids may be included.
- Uncontrolled cardiac disease, such as: New York Heart Association (NYHA) Class II or higher heart failure; unstable angina; myocardial infarction within the past year; clinically significant supraventricular or...
- History of allergy or hypersensitivity to any component of the treatment.
- History of malignant tumors within the past 5 years, except for completely treated basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, or ductal carcinoma in...
- Previously received systemic therapy for cholangiocarcinoma.
- Positive for hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) antibodies.
- Active infection requiring systemic treatment.
- Other conditions deemed unsuitable for inclusion by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, 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 Chengdu, Sichuan, 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.