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RecruitingPhase 2NCT06491472

Ivonescimab(AK112/SMT112) in Combination With Stereotactic Body Radiation Therapy and Chemotherapy in Patients With Pancreatic Cancer

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Trial Parameters

ConditionPancreatic Cancer
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study TypeINTERVENTIONAL
PhasePhase 2
Enrollment36
SexALL
Min Age18 Years
Max AgeN/A
Start Date2024-07-15
Completion2026-07-15
Interventions
IvonescimabGemcitabineNab paclitaxel

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Brief Summary

This study is an open-label, single-arm Phase II clinical study to evaluate the efficacy and safety of ivonescimab(AK112/SMT112) in combination with stereotactic body radiation therapy and chemotherapy in patients with pancreatic cancer

Eligibility Criteria

Inclusion Criteria: * Be able and willing to provide written informed consent and comply with all requirements of study participation (including all study procedures). * Histologically- or cytologically-confirmed diagnosis of pancreatic ductal adenocarcinoma (including adenosquamous carcinoma) * Have a life expectancy of at least 3 months. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator * No previous history of radiotherapy or no overlap between the secondary radiotherapy site and the original radiotherapy site * Has adequate organ function * All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment. Exclusion Criteria: * Has known active brain metastases or meningeal metastases * Compress

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