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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Iparomlimab and Tuvonralimab Injection (QL1706)
DrugGC chemotherapy and Iparomlimab and Tuvonralimab Injection
PULSAR
RadiationPersonalized Ultra-fractionated Stereotactic Adaptive Radiotherapy
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: PULSAR Combined with Immunotherapy and ChemotherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Safety of immunotherapy and chemotherapy combined with PULSAR radiation therapy
Evaluation of reported adverse events (AEs) and serious adverse events (SAEs), according to CTCAE v5.0. Evaluation of changes from Baseline during the Treatment and Follow-up periods
Time frame
Baseline, every three weeks in the treatment period, 30 days and 3 months after treatmentSecondary outcomes
1
immunological impact of immunotherapy and chemotherapy combined with PULSAR radiation therapy
Evaluation of 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 according to flow cytometry. Evaluation of changes from Baseline during the Treatment and Follow-up periodsTo investigate the
Time frame
Baseline, every three weeks in the treatment period, 30 days and 3 months after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wang Xin
Lead sponsor
West China Hospital
Sponsor institution
Source ClinicalTrials.gov