Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Recurrent Pancreatic Cancer

Phase 2

Recruiting

• Conditions: Recurrent Pancreatic Cancer
• Interventions: Drug: Tislelizumab; Drug: Nab paclitaxel; Drug: Gemcitabine

• Registration Number: NCT04902261
• Lead Sponsor: Changhai Hospital

Brief Summary

To evaluate the efficacy of Tislelizumab combined with Nab-paclitaxel and Gemcitabine in the treatment of recurrent pancreatic cancer

Detailed Description

There is heterogeneity in desmoplasia between different metastatic sites in pancreatic cancer. The tumor quasi-characteristics of patients with metastatic PDAC at presentation were more obvious than those of epithelial characteristics, and the quasi-and epithelial subtypes showed different responses to chemotherapy regimens, and the epithelial phenotype tumor quasi-phenotype was associated with metastasis-free survival. Therefore, different metastases of pancreatic cancer may respond differently to medical treatment. There were different metastases after postoperative recurrence of pancreatic cancer, 25.2% had only liver metastases, 14.7% had only lung metastases, 14.7% had multiple distant metastases, and about more than half of the patients had postoperative recurrence with only distant metastases and no in situ metastasis. Then whether there is a difference in the efficacy of PD1 drug therapy in patients with different metastases needs to be further verified.

Study Timeline

• Study Start: 2020-11-20
• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-26
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-01
• Primary Completion: 2023-11-20
• Study Completion: 2023-11-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Patients with radiologically or histologically confirmed postoperative Recurrent Pancreatic Cancer
• Patients with at least one measurable lesion (according to RECIST 1.1 criteria);
• Have not received gemcitabine-based regimen after surgery
• No systemic treatment after diagnosis of recurrence
• ECOG score 0-1
• Expected survival ≥ 3 months;
• Liver function is essentially normal: absolute neutrophil count > 1500/mm ³; platelet count > 100,000/mm ³; creatinine less than 1.5 times the upper limit of normal or calculated creatinine clearance (CRCI) > 45 mL/min; total bilirubin ≤ 2.0 mg/dL; aspartate aminotransferase (AST) and alanine aminotransferase less than 2.5 times the upper limit of normal
• Appropriate to participate in this trial as assessed by the investigator before entering the study
• Male and female subjects of childbearing potential must agree to use an effective method of contraception throughout the study
• Signed Informed Consent Form

Exclusion Criteria

• Patients who only undergo abdominal laparotomy but do not undergo resection of pancreatic tumor tissue
• Received gemcitabine-based regimen after surgery
• Systemic treatment after diagnosis of recurrence
• Patients with previous allergic reactions to similar drugs
• Pregnant or lactating patients
• Presence of pericardial effusion, uncontrolled pleural effusion, or clinically significant ascites at screening (including detectable ascites or ascites requiring puncture and aspiration on physical examination at screening)
• History of interstitial lung disease, pneumonitis, or uncontrolled systemic disease, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc
• Patients with severe cardiovascular diseases within 12 months before enrollment, such as symptomatic coronary heart disease, ≥ grade II congestive heart failure, uncontrolled arrhythmia, myocardial infarction, etc
• Presence of any active immunodeficiency or autoimmune disease and/or history of any immunodeficiency or autoimmune disease that may recur at screening (e.g., hypothyroidism or hyperthyroidism, interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, etc)
• Use of steroids or other systemic immunosuppressive therapy 14 days prior to enrollment
• Patients with other previous malignancies who are not cured
• Immunodeficient patients, such as HIV-positive
• Uncontrollable psychosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tislelizumab combined with Nab-paclitaxel and Gemcitabine	Tislelizumab	-
Tislelizumab combined with Nab-paclitaxel and Gemcitabine	Nab paclitaxel	-
Tislelizumab combined with Nab-paclitaxel and Gemcitabine	Gemcitabine	-
Nab-paclitaxel and Gemcitabine	Gemcitabine	-
Nab-paclitaxel and Gemcitabine	Nab paclitaxel	-

Primary Outcome Measures

Name	Time	Method
1-Year Survival Rates	Up to 2 years	The proportion of patients who survive more than 1 year after treatment.

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate（ORR)	Up to 2 years	the proportion of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR)
Progression Free Survival (PFS)	Up to 2 years	The time from the date of treatment to the first of either disease progression, relapse or death
Adverse Events (AEs)	Up to 2 years	the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0; Surgical safety including Intraoperative blood loss，PHLF assessed by ISGLS（2012），Postoperative complications evaluated by modified Clavien-Dindo system.
Overall survival (OS)	Up to 2 years	The time from the date of treatment start to the date of death or to the date of last follow-up for patients alive

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, China