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

Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study ID
NCT06491472
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ivonescimab — DRUG
    20mg/kg,IV,d1,Q3W
  • Gemcitabine — DRUG
    1000mg/m2, IV, d1/8, Q3W
  • Nab paclitaxel — DRUG
    125mg/m2, IV, d1/8, Q3W
  • SBRT — RADIATION
    5Gy \*5 F

Study Details

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

Key Dates

Start date
Jul 15, 2024
Status verified
May 2024
Primary completion
Jul 15, 2026
Completion
Jul 15, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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)

Primary Outcome Measure

Objective Response Rate(ORR) [ Time Frame: Up to approximately 2 years ]

Central Contacts

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