Clinical trial · Interventional

Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer

A Randomized, Open-label, Multi-center Phase III Clinical Study of Liposomal Irinotecan Combined With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine for Postoperative Adjuvant Treatment of Pancreatic Cancer

NCT06571461CI-TRIAL-00080226not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This study will evaluate the efficacy and safety of adjuvant therapy with liposomal irinotecan in combination with oxaliplatin, and S-1 compared with capecitabine combined with capecitabine in participants with pancreatic ductal adenocarcinoma after radical surgery.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Pancreatic Cancer	Malignant Pancreatic Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
Capecitabine	Drug	Capecitabine	ALIAS
Gemcitabine	Drug	Gemcitabine	ALIAS
Liposomal Irinotecan	Drug	—	UNRESOLVED
Oxaliplatin	Drug	Oxaliplatin	ALIAS
S-1	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
NASOX：Liposomal Irinotecan; Oxaliplatin; S-1
description
Liposomal irinotecan at a dose of 50 mg/m² is administered intravenously over 90 minutes on D1. Oxaliplatin is administered at a dose of 60 mg/m² intravenously over 2 hours on D1. S-1 at a dose of 40 to 60mg twice daily is taken orally for 7 consecutive days, followed by a 7-day break. These medications are administered once every 2 weeks for a total of 12 cycles.
interventionNames
1. Drug: Liposomal Irinotecan
2. Drug: Oxaliplatin
3. Drug: S-1
type
ACTIVE_COMPARATOR
label
GX：Gemcitabine; Capecitabine
description
Gemcitabine at a dose of 1000mg/m² is administered via intravenous infusion over 30 minutes on D1, 8, and 15 of a 28-day cycle. Capecitabine at a dose of 1660mg/m² per day in two divided oral doses is taken for 21 consecutive days, followed by a 7-day rest period. These medications are administered once every 4 weeks for a total of 6 cycles.
interventionNames
1. Drug: Gemcitabine

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

Inclusion Criteria:

1. Patients able and willing to provide a written informed consent aged 18-75 years.
2. Histologically confirmed resected ductal pancreatic adenocarcinoma (including adenosquamous carcinoma).
3. Undergone radical resection and confirmed macroscopic complete resection (R0 and R1).
4. Full recovery after surgery; able to start adjuvant treatment within 12 weeks after surgery.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
6. The main organs function well.

Exclusion Criteria:

1. Patients with other types of non-ductal tumor of the pancreas, including endocrine tumors or acinar cell adenocarcinoma, pancreatoblastoma, and solid-pseudopapillary tumor.
2. Macroscopic incomplete tumor removal (R2 resection).
3. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.
4. Presence or history of metastatic or locally recurrent pancreatic adenocarcinoma.
5. CA 19-9\> 180 U / ml within 21 days before randomization.
6. The toxicity of previous therapy has not recovered to Grade 1 or below.
7. Known peripheral neuropathy (CTCAE ≥ Grade 2).
8. Known deficiency of dihydropyrimidine dehydrogenase (DPD)
9. Subjects with a confirmed diagnosis of Gilbert's syndrome

References

Publications (0)

Data not yet available

No reference posted for this study.