Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of
This study is a prospective, multicenter, randomized, controlled Ⅲ period clinical trials.A total of 600 patients with resectable pancreatic cancer assessed by imaging and serum CA125≥35 U/mL were randomly assigned according to the ratio of 1:1 (300 cases: 300 cases) between the direct surgical resection group and the neoadjuvant chemotherapy group, to observe the efficacy and safety of patients with resectable pancreatic cancer with elevated serum CA125 with or without neoadjuvant chemotherapy.Neoadjuvant chemotherapy and adjuvant chemotherapy can use albumin-binding paclitaxel combined with gemcitabine (AG) regimen or mFOLFirinox (5-FU, calcium leucofolate [LV], irinotecan, oxaliplatin) regimen. AG regimen was given on day 1, 8, 15, and repeated every 4 weeks.The mFOLFIRINOX regimen was administered on days 1 and 15 and repeated every 4 weeks.Patients in the neoadjuvant chemotherapy group were treated with 4 courses of neoadjuvant chemotherapy (AG regimen or mFOLFIRINOX regimen) immediately after the pathologic diagnosis of pancreatic adenocarcinoma was confirmed by puncture.Patients receiving neoadjuvant chemotherapy will undergo surgical exploration to assess the resectability of the tumor.Four to eight weeks after radical resection, the patients were treated with adjuvant chemotherapy from the recovery of surgical trauma. The choice of adjuvant chemotherapy after surgery depended on the response to neoadjuvant chemotherapy.If neoadjuvant chemotherapy is effective, adjuvant chemotherapy will maintain the original regimen;If neoadjuvant chemotherapy is ineffective but radical surgery is still feasible, adjuvant chemotherapy will be used with a crossover regimen.Neoadjuvant chemotherapy group received adjuvant chemotherapy for 2 courses.In the direct surgical resection group, 6 courses of adjuvant chemotherapy were started 4 to 8 weeks after radical resection.Relevant examinations should be conducted before and after each course of medication to evaluate safety events. Imaging reexaminations should be conducted every 2 courses of medication, and imaging reexaminations should be conducted every 3 months during follow-up to evaluate disease recurrence.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nab-paclitaxel and Gemcitabine | Experimental | Albumin combined with paclitaxel 125mg/m2 intravenous infusion, Day 1, 8, 15;Gemcitabine 1000 mg/m2 was given intravenously for more than 30min on days 1, 8, and 15, and repeated every 4 weeks. |
|
| mFOLFIRINOX | Experimental | Oxaliplatin 85 mg/m2 intravenous infusion for 2 h, Day 1;LV 400 mg/m2 intravenous infusion for 2 h, Day 1;Irinotecan 150 mg/m2 was added 30 min after intravenous infusion for 90 min, day 1;This was immediately followed by a continuous intravenous infusion of 5-FU 2400 mg/m2 for 46 h.Repeat every 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nab paclitaxel | Drug | Albumin combined with paclitaxel 125mg/m2 intravenous infusion, Day 1, 8, 15 |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | • To observe the overall survival of patients with resectable pancreatic cancer with elevated serum CA125 with and without neoadjuvant chemotherapy | from randomization to death, up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free survival | To observe the relapse-free survival of patients with resectable pancreatic cancer with elevated serum CA125 versus without neoadjuvant chemotherapy | from randomization to recurrence, up to 36 months |
| Surgical excision rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xian-Jun Jun, M.D., Ph.D. | Contact | 86 21 64175590 | xiahuanyu@fudanpci.org | |
| Wen-Quan Wang, M.D., Ph.D. | Contact | +86 21 64175590 | wangwenquan@fudanpci.org |
| Name | Affiliation | Role |
|---|---|---|
| Xian-Jun Jun, M.D., Ph.D. | Fudan University | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013660 | Taxes |
| D000068196 | Albumin-Bound Paclitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Gemcitabine | Drug | Intravenous infusion of 1000 mg/m2 was given for more than 30min on days 1, 8, and 15, and repeated every 4 weeks |
|
|
| mFOLFIRINOX | Drug | Oxaliplatin 85 mg/m2 intravenous infusion for 2 h, Day 1;LV 400 mg/m2 intravenous infusion for 2 h, Day 1;Irinotecan 150 mg/m2 was added 30 min after intravenous infusion for 90 min, day 1;This was immediately followed by a continuous intravenous infusion of 5-FU 2400 mg/m2 for 46 h.Repeat every 2 weeks. |
|
|
• To observe the resectable rate of patients with resectable pancreatic cancer with elevated serum CA125 with and without neoadjuvant chemotherapy
| from randomization to recurrence, up to 36 months |
| Incidence of adverse events | • To observe the Incidence of adverse events of patients with resectable pancreatic cancer with or without neoadjuvant chemotherapy with elevated serum CA125 | from randomization to recurrence, up to 36 months |
| D043822 |
| Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |