PULSAR Combined With Immunotherapy and Chemotherapy
ConditionCholangiocarcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWang Xin
About this trial
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.
Eligibility criteria
Qualifiers
Signed informed consent. The subject has fully understood and accepted the purpose, content, expected efficacy, 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.
Disqualifiers
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-interventional) clinical study or the follow-up phase of an interventional clinical study.
Previously received radiotherapy to the upper abdomen.
Trial design
Treatments tested in this trial
- Iparomlimab and Tuvonralimab Injection (QL1706)
- PULSAR
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Wang Xin
Lead sponsor
West China Hospital
Sponsor institution
Source ClinicalTrials.gov