Pancreatic Cancer, Adjuvant Therapy
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of irinotecan liposome injection in combined with oxaliplatin plus tegafur (NASOX) for postoperative adjuvant chemotherapy for pancreatic cancer.
Interventions
Postoperative adjuvant therapy
Sponsors
CSPC Ouyi Pharmaceutical Co., Ltd.
Kuirong Jiang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. ECOG performance status 0 or 1. 2. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). 3. ECOG performance status 0 or 1. 4. Life expectancy of greater than or equal to 6 months. 5. Able and willing to provide a written informed consent.
Exclusion criteria
1. Patients who cannot eat orally and have gastric emptying disorder after surgery; 2. Patients with moderate diarrhea: diarrhea ≥4 times per day; the moderate and severe effluents from stoma increased; Or diarrhea that limits activities of daily living; 3. Patients who cannot eat orally and have gastric emptying disorder after surgery; 4. Patients who cannot eat orally and have gastric emptying disorder after surgery;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Free Survival, DFS | baseline up to approximately 21.6 months. | the time from the start of randomization (or the start of treatment in a one-arm trial) to the recurrence of disease or death from any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (aes) were determined and graded according to NCI-CTCAE version 5.0, and evaluated by the overall incidence of AE, the incidence of AE grade 3 or above, and the incidence of SAE | baseline up to approximately 7 months. | Hematologic and non-hematologic adverse events during adjuvant therapy (according to NCI-CTCAE5.0); |
| Overall Survival, OS | baseline up to approximately55 months. | the time from the start of randomization (or the start of treatment in a one-arm trial) to death from any cause. |
| Quality of life, QOL | baseline up to approximately 55 months. | It reflects the ability of human activities to improve the survival level and survival chances, evaluated according to EORTC Quality of life measurement scale QLQ-C30 V3.0 assessment. |
| The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy | baseline up to approximately 7 months. | The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy |
| he results were presented in terms of the proportion of patients who were replaced with 5-FU/LV due to Tegafur intolerance | baseline up to approximately 7 months. | The results were presented in terms of the proportion of patients who completed 6 months of chemotherapy and the proportion of patients who were replaced with 5-FU/LV due to Tegafur intolerance |
Countries
China
Contacts
Primary ContactKuiRong Jiang, archiater
Outcome results
None listed