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

Sponsor
Changhai Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04902261
Collaborator
(none)
140
1
2
36
3.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Exploratory Study of Tislelizumab Combined With Nab-paclitaxel and Gemcitabine for Postoperative Recurrence of Pancreatic Cancer
Actual Study Start Date :
Nov 20, 2020
Anticipated Primary Completion Date :
Nov 20, 2022
Anticipated Study Completion Date :
Nov 20, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 1-Year Survival Rates [Up to 2 years]

    The proportion of patients who survive more than 1 year after treatment.

Secondary Outcome Measures

  1. 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)

  2. 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

  3. 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

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Changhai Hospital Shanghai China 200433

Sponsors and Collaborators

  • Changhai Hospital

Investigators

  • Principal Investigator: Gang Jin, Doctor, Changhai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guo ShiWei, Principal Investigator, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT04902261
Other Study ID Numbers:
  • CHEC2020-144
First Posted:
May 26, 2021
Last Update Posted:
May 26, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2021