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A Phase III Study of Ivonescimab + Chemo With/Without AK117 in Metastatic Pancreatic Cancer

RecruitingPhase 3Ages 18 Years - 75 YearsAllAkeso
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In plain words

What the trial is, and whether it could suit you

This is a Phase 3, randomized, double-blind clinical trial aimed at evaluating the efficacy and safety of Ivonescimab plus chemotherapy with or without AK117 versus placebo plus chemotherapy in patients with metastatic pancreatic cancer. The study seeks to determine whether the addition of Ivonescimab and/or AK117 improves clinical outcomes compared to standard chemotherapy alone. Participants will be randomly assigned to receive either Ivonescimab with/without AK117 or placebo, both in combination with chemotherapy.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Voluntarily sign a written informed consent form. 2. Age at enrollment is โ‰ฅ 18 and โ‰ค 75 years, both males and females are eligible. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Life expectancy of โ‰ฅ 3 months. 5. Histologically or cytologically confirmed, unresectable metastatic pancreatic ductal adenocarcinoma (PDAC). 6. No prior systemic anti-cancer treatment for metastatic PDAC. 7. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 8. Adequate organ function. Exclusion Criteria: 1. Histologically or cytologically confirmed other types of pancreatic malignancies or mixed histology types. 2. Presence of active central nerve system (CNS) metastases. 3. Known germline BRCA1/2 or PALB2 mutations. 4. Clinically significant or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage. 5. History of other malignancies within the past 5 years. 6. History of significant bleeding tendencies or coagulopathy; clinically significant bleeding events within 1 month before the first dose. 7. Previous anti-angiogenic therapy and immunotherapy. 8. Active autoimmune disease requiring systemic treatment within the past 2 years. 9. Pregnant or breastfeeding women. 10. Concurrent participation in another clinical trial, unless it is an observational or non-interventional study or in the follow-up phase of an interventional study.
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What it tests

  • Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine
  • Ivonescimab, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine
  • Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine
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Where

3 sites
Harbin Medical University Cancer Hospital
Harbin, China
Fudan University Shanghai Cancer Center
Shanghai, China
Zhejiang Cancer Hospital
Hangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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