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

NCT ID: NCT04902261

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-20
• Study Completion Date: 2023-11-20

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.

Conditions

Recurrent Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tislelizumab combined with Nab-paclitaxel and Gemcitabine

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

Tislelizumab 200 mg every three weeks

Nab paclitaxel

Intervention Type: DRUG

Nab-paclitaxel 125mg/m2 on d1 and d8 every three weeks

Gemcitabine

Intervention Type: DRUG

Gemcitabine 1000mg/m2 on d1 and d8 every three weeks

Nab-paclitaxel and Gemcitabine

Group Type: ACTIVE_COMPARATOR

Nab paclitaxel

Intervention Type: DRUG

Nab-paclitaxel 125mg/m2 on d1 and d8 every three weeks

Gemcitabine

Intervention Type: DRUG

Gemcitabine 1000mg/m2 on d1 and d8 every three weeks

Interventions

Tislelizumab

Tislelizumab 200 mg every three weeks

Intervention Type: DRUG

Nab paclitaxel

Nab-paclitaxel 125mg/m2 on d1 and d8 every three weeks

Intervention Type: DRUG

Gemcitabine

Gemcitabine 1000mg/m2 on d1 and d8 every three weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guo ShiWei

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gang Jin, Doctor

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

Changhai Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Shiwei Guo, Doctor

Role: CONTACT

gestwa@163.com

+8618621500666

Facility Contacts

Shiwei Guo, Doctor

Role: primary

gestwa@163.com

+8618621500666

Other Identifiers

CHEC2020-144

Identifier Type: -

Identifier Source: org_study_id