NCT06844422 Adapted Guided Stereotactic Body Radiotherapy Combined With Chemotherapy and Enhancement of Novel Drug Ivonescimab for Pancreatic Cancer (ASCEND)
| NCT ID | NCT06844422 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shandong Cancer Hospital and Institute |
| Condition | Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 37 participants |
| Start Date | 2025-02-08 |
| Primary Completion | 2028-02-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 37 participants in total. It began in 2025-02-08 with a primary completion date of 2028-02-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to evaluate the safety and efficacy of Ivonescimab, a bispecific antibody targeting PD-1 and VEGF, in combination with stereotactic body radiotherapy (SBRT) and chemotherapy for treating locally advanced pancreatic cancer (LAPC). The Phase Ib portion is a dose-escalation study to determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and the recommended Phase II dose (RP2D) of Ivonescimab. The Phase II portion will assess the median progression-free survival (mPFS) of patients receiving Ivonescimab with SBRT (25-50Gy/5F) and modified FOLFIRINOX chemotherapy. The study aims to provide critical insights into treatment options for LAPC and inform future therapeutic strategies.
Eligibility Criteria
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.
Contact & Investigator
Jinbo Yue, Doctor
PRINCIPAL INVESTIGATOR
Shandong Cancer Hospital and Institute
Frequently Asked Questions
Who can join the NCT06844422 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06844422 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06844422 currently recruiting?
Yes, NCT06844422 is actively recruiting participants. Contact the research team at jbyue@sdfmu.edu.cn for enrollment information.
Where is the NCT06844422 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06844422 clinical trial?
NCT06844422 is sponsored by Shandong Cancer Hospital and Institute. The principal investigator is Jinbo Yue, Doctor at Shandong Cancer Hospital and Institute. The trial plans to enroll 37 participants.
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