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Ivonescimab(AK112/SMT112) in Combination With Stereotactic Body Radiation Therapy and Chemotherapy in Patients With Pancreatic Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

Efficacy and Safety of Ivonescimab(AK112/SMT112) in Combination With Stereotactic Body Radiation Therapy and Chemotherapy in Patients With Pancreatic Cancer：A Single-arm, Open-label, Phase II Clinical Study

NCT06491472•Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
•Compression fractures of the spine not treated with surgery and/or radiation; Treated spinal compression fractures require stable disease for at least 2 weeks randomization
•There was a high risk of gastrointestinal bleeding or abdominal bleeding
•Uncontrolled cancer pain; Anesthetic painkillers did not reach a stable dose at the time of enrollment
•During the initial 72 hours of the study, patients experienced a weight loss of 10 percent or more compared to their initial body weight when they signed the ICF
•Within 72 hours prior to the study, the subjects' ECOG physical status score increased by ≥1 point compared to the score at ICF signing.
•Unable to lie flat or for 10-20 minutes with radiotherapy.
•Prior exposure to any agent targeting T cell costimulation or immune checkpoint pathways (e.g., anti-PD 1, anti-PD L1, anti-PD L2, anti-CTLA 4, anti CD137 or anti-OX40 antibody, etc)
•Known germ line BRAC1/2 mutation
•Liver metastases account for more than 50% of the total liver volume
+15 more criteria

Locations (1)

Wuhan Union Hospital of China

Wuhan, China

Key Dates

Start Date

July 15, 2024

Primary Completion Date

July 15, 2026

Completion Date

July 15, 2027

Last Updated

July 9, 2024

Enrollment

ESTIMATED participants

Conditions

Pancreatic Cancer

Interventions

Ivonescimab

DRUG

Gemcitabine

DRUG

Nab paclitaxel

DRUG

SBRT

RADIATION

Contacts

Tao Zhang

CONTACT

13808640033 1277577866@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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