DDP ip Combined With AG in PDAC With Peritoneal Metastasis

Pancreatic Neoplasm Clinical Trial

Official title:

Intraperitoneal (IP) Cisplatin Combined With Intravenous Gemcitabine + Nab-paclitaxel in Patients With Pancreatic Cancer With Peritoneal Metastasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05222204
• Other study ID #: CSPAC-38
• Status: Recruiting
• Phase: Phase 2
• Start date: July 2, 2021
• Est. completion date: July 2, 2023

Study information

• Verified date: February 2022
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: July 2, 2023
• Est. primary completion date: July 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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. The imaging assessment is abdominal metastasis or peritoneal thickening; or CA199/CA125 is elevated in the course of the disease but no other solid organ metastasis is found;

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.

Related Conditions & MeSH terms

• Pancreatic Neoplasm
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University	Shanghai	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	patients the time from enrollment to death from any cause	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