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

Prospective Exploratory Study of Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Postoperative Recurrence of Pancreatic Cancer

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

Study Overview

• Status: Recruiting
• Conditions: Recurrent Pancreatic Cancer
• Intervention / Treatment: Drug: Tislelizumab; Drug: Nab paclitaxel; Drug: Gemcitabine

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 Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shiwei Guo, Doctor; Phone Number: +8618621500666; Email: gestwa@163.com

Study Locations

• China
  • Shanghai, China, 200433
    • Recruiting
    • Changhai Hospital
    • Contact: Shiwei Guo, Doctor; Phone Number: +8618621500666; Email: gestwa@163.com
    • Principal Investigator: Gang Jin, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tislelizumab combined with Nab-paclitaxel and Gemcitabine	Drug: Tislelizumab; Tislelizumab 200 mg every three weeks; Drug: Nab paclitaxel; Nab-paclitaxel 125mg/m2 on d1 and d8 every three weeks; Drug: Gemcitabine; Gemcitabine 1000mg/m2 on d1 and d8 every three weeks
Active Comparator: Nab-paclitaxel and Gemcitabine	Drug: Nab paclitaxel; Nab-paclitaxel 125mg/m2 on d1 and d8 every three weeks; Drug: Gemcitabine; Gemcitabine 1000mg/m2 on d1 and d8 every three weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-Year Survival Rates	The proportion of patients who survive more than 1 year after treatment.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate（ORR)	the proportion of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR)	Up to 2 years
Progression Free Survival (PFS)	The time from the date of treatment to the first of either disease progression, relapse or death	Up to 2 years
Overall survival (OS)	The time from the date of treatment start to the date of death or to the date of last follow-up for patients alive	Up to 2 years
Adverse Events (AEs)	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.	Up to 2 years

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Principal Investigator: Gang Jin, Doctor, Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Estimated): November 20, 2023
• Study Completion (Estimated): November 20, 2023

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Paclitaxel; Gemcitabine; Tislelizumab
• Other Study ID Numbers: CHEC2020-144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No