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

Recurrent Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04902261
• Other study ID #: CHEC2020-144
• Status: Recruiting
• Phase: Phase 2
• Start date: November 20, 2020
• Est. completion date: November 20, 2023

Study information

• Verified date: August 2023
• Source: Changhai Hospital
• Contact: Shiwei Guo, Doctor
• Phone: +8618621500666
• Email: gestwa[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: November 20, 2023
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms
• Recurrent Pancreatic Cancer

Intervention

Drug:
• Tislelizumab
Tislelizumab 200 mg every three weeks
• Nab paclitaxel
Nab-paclitaxel 125mg/m2 on d1 and d8 every three weeks
• Gemcitabine
Gemcitabine 1000mg/m2 on d1 and d8 every three weeks

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-Year Survival Rates	The proportion of patients who survive more than 1 year after treatment.	Up to 2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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