NCT06259058Not yet recruitingPhase 1/2
Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer
Evaluate the Efficacy and Safety of Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer: a Phase Ib/II, Multicenter, Open-label Trial
Source: ClinicalTrials.gov · Last updated 15 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This multicentric open-label trial will compare the efficacy and safety of stereotactic body radiation therapy (SBRT) followed by NALIRIFOX (5-fluorouracil, leucovorin, irinotecan liposome injection and oxaliplatin) vs NALIRIFOX for borderline resectable pancreatic cancer (BRPC).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- First submitted
- 6 Feb 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 1 Apr 2026
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Pancreatic cancer
- NCT number
- NCT06259058
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 96
- From 1 Apr 2024 to the primary completion date, 1 Apr 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with distant metastases and/or cannot complete resection.
- Patients who have chemotherapy and surgery contraindications.
- Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1 within 14 days before the first administration.
- Participated in other trial within 30 days before the first administration.
Other illness
- Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc.
- Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.
- Active HIV, HBV, HCV infection.
- Combined with uncontrollable systemic diseases.
- Presence of severe gastrointestinal disease (including active bleeding, \> grade 1 obstruction \[CTCAE v5.0\], or \> grade 1 diarrhea \[CTCAE v5.0\]).
- History of allergy or hypersensitivity to drug or any of their excipients.
Lab values
- Documented serum albumin ≤3 g/dL
Age
- Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception.
Other
- Patients who are not suitable to participate in this trial for any reason judged by the investigator.
Who the study is looking for
- Age: ≥18 years old.
- Histologically or cytologically proven pancreatic ductal adenocarcinoma.
- Multidisciplinary assessment as borderline resectable disease.
- At least one measurable lesion (according to RECIST v1.1).
- No prior antitumor therapy for pancreatic cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 \~ 1.
- The expected survival time ≥3 months.
- Adequate bone marrow function as evidenced by: 1) Absolute neutrophil count (ANC) ≥1.5×10\^9/L, 2) Platelet count ≥100×10\^9/L, 3) Hemoglobin (Hb) ≥90 g/L, 4) White blood cell (WBC) ≥3.0×10\^9/L.
- Adequate hepatic function as evidenced by: 1) Serum total bilirubin ≤1.5 × upper limit of normal (ULN), 2) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN
- Adequate renal function as evidenced by serum creatinine (Cr)≤1.5 × ULN or creatinine clearance ≥60 mL/min.
- Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.