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

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Wuhan Union Hospital of China
RECRUITING
Wuhan
Contact Information
Primary
Tao Zhang
1277577866@qq.com
13808640033
Time Frame
Start Date: 2024-07-15
Estimated Completion Date: 2027-07-15
Participants
Target number of participants: 36
Treatments
Experimental: Ivonescimab(AK112/SMT112)+SBRT+gemcitabine+nab-paclitaxel
Ivonescimab(AK112/SMT112) (20mg/kg,Q3W) +gemcitabine(1000 mg/m²,IV, d1/8, Q3W)+nab-paclitaxel(25mg/m2, IV, d1/8, Q3W)~+SBRT(5Gy \*5 F)
Related Therapeutic Areas
Sponsors
Leads: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborators: Akesobio

This content was sourced from clinicaltrials.gov

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