NCT06383078Not yet recruitingPhase 2
HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer
HR070803 in Combination With Oxaliplatin Plus Tegafur Versus HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate as Adjuvant Therapy for Pancreatic Cancer: A Multicenter, Multi-cohort, Randomized, Phase II Study
Source: ClinicalTrials.gov · Last updated 25 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of this study is to evaluate the efficacy and safety of HR070803 in Combination With Oxaliplatin plus Tegafur compared to HR070803 in combination with oxaliplatin, 5-fluorouracil/leucovorin (5FU/LV) treatment as adjuvant therapy in patients with resected pancreatic cancer.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 3 Apr 2024
- Start date
- 20 Apr 2024
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Pancreatic cancer
- NCT number
- NCT06383078
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 20 Apr 2024 to the primary completion date, 1 Mar 2027
- 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
- CA19-9 exceeding normal value within 14 days prior to enrollment.
- Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.
- Severe infection (\> CTCAE grade 2), such as severe pneumonia, bacteremia, infection complications, etc. requiring inpatient treatment, occurred within four weeks before enrollment, and symptoms and signs of infection requiring intravenous antibiotic therapy (except for prophylactic antibiotics) occurred within two weeks before enrollment;
Other illness
- Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor;
- Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma.
- Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Patients with NYHA class 2 and above cardiac failure; (2) unstable angina; (3) myocardial infarction that occurred within 6 months; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
Who the study is looking for
- Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).
- ECOG performance status 0 or 1.
- Life expectancy of greater than or equal to 6 months.
- Full recovery from surgery and patient is scheduled to start treatment within 3 weeks to 12 weeks after surgery.
- The number of lymph nodes dissected during resection ≥ 15.
- Able and willing to provide a written informed consent.
Age in the registry: 20 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.