Combining a new drug with radiation and chemotherapy for pancreatic cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of Ivonescimab, a bispecific antibody targeting PD-1 and VEGF, in conjunction with stereotactic body radiotherapy (SBRT) and chemotherapy for patients with locally advanced pancreatic cancer (LAPC). The study consists of two phases: the first phase focuses on determining the maximum tolerated dose of Ivonescimab, while the second phase assesses the median progression-free survival of patients receiving the treatment combination. A total of 37 patients will be recruited, and the trial aims to provide critical insights into new treatment options for LAPC.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Pathologically or cytologically confirmed unresectable LAPC, as defined by the 8th edition of the American Joint Committee on Cancer (AJCC);
2. Age between 18 and 80 years;
3. At least one measurable pancreatic cancer lesion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
5. Life expectancy of at least 3 months;
6. Adequate hematological, renal, and hepatic function, as defined by the following criteria (within 14 days prior to enrollment): (1) Hemoglobin (Hb) ≥ 90 g/L; Absolute Neutrophil Count (ANC) ≥ 1.0 × 10\^9/L; Platelet count (PLT) ≥ 75 × 10\^9/L; (2) No significant organ dysfunction, with the following criteria: Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) or direct bilirubin ≤ ULN if total bilirubin \> 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Alkaline phosphatase (ALP) ≤ 2.5 × ULN, or ≤ 2.5 × ULN for the liver fraction if ALP \> 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance (using the MDRD formula) ≥ 40 mL/min if serum creatinine is \> 1.5 × ULN; Urine protein \< 2+, or if ≥ 2+ on dipstick, 24-hour urine protein must be \< 2 g or the urine protein-to-creatinine ratio (UPC) must be \< 2; International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN;
7. Ability to provide tissue and blood samples for translational research;
8. Ability to comprehend study details and provide written informed consent.

Exclusion Criteria:

1. History of any malignant tumors within the past 5 years, except for cured localized tumors;
2. Uncontrolled infections (e.g., active tuberculosis or hepatitis), uncontrolled systemic diseases, poorly controlled hypertension or diabetes, or severe comorbidities within the past six months, including myocardial infarction, cerebral embolism, or significant arrhythmias;
3. Previous treatment with drugs targeting other stimulatory or co-inhibitory T-cell receptors;
4. Prior radiotherapy within 2 weeks before enrollment;
5. Known allergy to Ivonescimab or its excipients;
6. Pregnancy or lactation;
7. Current or planned use of strong CYP3A4/5 or CYP1A2 inducers or strong CYP3A4/5 inhibitors;
8. Requirement for oral vitamin K antagonists for anticoagulation. Low-dose warfarin (≤ 2 mg/day) and other low-dose anticoagulants for maintaining central venous access or preventing deep vein thrombosis are permitted. Low-molecular-weight heparin is also permitted;
9. Conditions affecting oral medication administration, such as a history of gastrointestinal perforation or fistula within the past 6 months, history of intestinal obstruction, extensive bowel resection, Crohn's disease, ulcerative colitis, or chronic diarrhea.

Where it's running

• Shandong Cancer Hospital and Institute
  Jinan, Shandong, China Recruiting

Study contacts

• Principal investigator: Jinbo Yue, Doctor — Shandong Cancer Hospital and Institute
• Study coordinator: Jinbo Yue, Doctor
• Email: jbyue@sdfmu.edu.cn
• Phone: 0531-67626442

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Ivonescimab plus chemotherapy, with or without AK117, for metastatic pancreatic cancer

  This trial will test whether adding the antibody Ivonescimab, with or without AK117, to standard chemotherapy helps people with metastatic pancreatic cancer live longer or have better tumor responses.

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• Ivonescimab combined with AG regimen for borderline resectable pancreatic cancer

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• Combining Ivonescimab with Radiation and Chemotherapy for Pancreatic Cancer

  This study is testing if combining a new drug called ivonescimab with radiation and chemotherapy can help people with pancreatic cancer feel better and improve their treatment outcomes.

  Recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan · NCT06491472

• Integrated genomic and clinical database for cancer biomarker discovery

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• Using contrast-enhanced ultrasound to check for local pancreatic cancer recurrence after surgery

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• Combination of ivermectin with standard skin-protective care for daraxonrasib-related skin toxicity in pancreatic cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.