Clinical trial NCT05222204: DDP ip Combined With AG in PDAC With Peritoneal Metastasis
Official title: Intraperitoneal (IP) Cisplatin Combined With Intravenous Gemcitabine + Nab-paclitaxel in Patients With Pancreatic Cancer With Peritoneal Metastasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Neoplasm
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: two cohort: cohort A (first-line) and cohort B (post-line with malignant ascites )
Primary purpose: TREATMENT

Brief summary: intraperitoneal (IP) Cisplatin combined with intravenous gemcitabine + nab-paclitaxel in patients with pancreatic cancer with peritoneal metastasis


Eligibility criteria: Inclusion Criteria:

cohort A

Patients should meet the following criteria before treatment to be included in the trial:

1. Voluntarily participate and sign the informed consent;
2. Age ≥18 years old and ≤75 years old, gender is not limited;
3. ECOG score ≤2 points;
4. Pathological diagnosis of pancreatic adenocarcinoma;
5. Advanced pancreatic cancer with intra-abdominal metastasis in imaging assessment, or intra-operative intra-operative findings of intra-abdominal metastasis;
6. The time from the end of adjuvant chemotherapy after surgery is more than 6 months, or they have not received any form of anti-tumor therapy before, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, and molecular targeted therapy;
7. No serious abnormal blood system, heart, lung function and immune deficiency (refer to their respective standards);
8. Blood routine indicators: white blood cells ≥3 × 109/L; absolute neutrophil count ≥1.5 × 109/L; platelets ≥100 × 109/L; hemoglobin ≥9 g/dL;
9. Blood biochemical indexes: AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ ULN; serum creatinine (CRE) ≤ 1.5 × ULN;
10. Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤ 1.5 × ULN;
11. Able to comply with research visit plans and other protocol requirements.

inclusion criteria (Cohort B)

Patients should meet the following criteria before treatment to be included in the trial:

1. Voluntarily participate and sign the informed consent;
2. Age ≥18 years old and ≤75 years old, gender is not limited;
3. ECOG score ≤2 points;
4. Pathological diagnosis of pancreatic adenocarcinoma;
5. malignant ascites with positive peritoneal cytology or Laparoscopic exploration processed.
6. At least one systemic chemotherapy has been used;
7. No serious abnormal blood system, heart, lung function and immune deficiency (refer to their respective standards);
8. Blood routine indicators: white blood cells ≥3 × 109/L; absolute neutrophil count ≥1.5 × 109/L; platelets ≥100 × 109/L; hemoglobin ≥9 g/dL;
9. Blood biochemical indexes: AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal (ULN); total bilirubin (TBIL) ≤ ULN; serum creatinine (CRE) ≤ 1.5 × ULN;
10. Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤ 1.5 × ULN;
11. Able to comply with research visit plans and other protocol requirements.

Exclusion Criteria:

Patients were excluded from the study if they met any of the following criteria:

1. Associated with other systemic malignant tumors;
2. Single kidney, deformed kidney or poor renal compensation;
3. Have used any other study drug within 7 days before chemotherapy;
4. Patients with central nervous system disease, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled;
5. There is a history of allergy to the study drug or drugs of similar structure;
6. Patients who are using and require long-term use of warfarin anticoagulation.

Primary outcomes:
measure: overall survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: