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Status unknownNCT04902261Updated Sep 1, 2023

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

A Phase 2 interventional study of Tislelizumab and Nab paclitaxel in Recurrent Pancreatic Cancer, sponsored by Changhai Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-01.

Sponsored by Changhai Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Nov 2020, registered May 2021).
Phase
Phase 2
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Recurrent Pancreatic Cancer
03

In context

Pancreatic Neoplasms

3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.

This study's planned enrollment of 140 is above the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Changhai Hospital is the lead sponsor of 354 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    Tislelizumab combined with Nab-paclitaxel and Gemcitabine

    Drug: Tislelizumab · Drug: Nab paclitaxel · Drug: Gemcitabine

  • Active comparator
    Nab-paclitaxel and Gemcitabine

    Drug: Nab paclitaxel · Drug: Gemcitabine

Interventions

  • Tislelizumab 200 mg every three weeks

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

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

06

What researchers measure

Primary outcomes

  1. 1-Year Survival Rates

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

    Time frame: Up to 2 years

Secondary outcomes

  1. Overall Response Rate(ORR)

    the proportion of patients who had a best overall tumor response rating of complete response (CR) or partial response (PR)

    Time frame: Up to 2 years

  2. Progression Free Survival (PFS)

    The time from the date of treatment to the first of either disease progression, relapse or death

    Time frame: Up to 2 years

  3. 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

    Time frame: Up to 2 years

  4. 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.

    Time frame: Up to 2 years

07

Study locations

1 of 1 sites recruiting
  • Changhai Hospital
    Shanghai, 200433, China
    • Shiwei Guo, Doctor · Contact · gestwa@163.com · +8618621500666
    • Gang Jin, Doctor · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2020 (actual). Primary completion is estimated for Nov 2023, 36 months after the start.

Of 297 non-industry phase 2 interventional studies under Pancreatic Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 80. This study's planned 36 months is below that.

Counting every sponsor, half of 364 studies reached it within 57 months; a quarter within 34 and three quarters within 80.

How these figures are worked out, and which studies are left out of them.

Registered
May 20, 2021
First posted
May 26, 2021
StartActual
Nov 20, 2020
Primary completionEst.
Nov 20, 2023
CompletionEst.
Nov 20, 2023
Last update
Sep 1, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04902261
Lead sponsor
Changhai Hospital
Responsible party
Guo ShiWei (Principal Investigator, Changhai Hospital) — Principal investigator
First posted
May 26, 2021
Start date
Nov 20, 2020
Primary completion
Nov 20, 2023 (estimated)
Completion
Nov 20, 2023 (estimated)
Last update
Sep 1, 2023

Study contacts

Shiwei Guo, Doctor
Contact
gestwa@163.com
+8618621500666
Gang Jin, Doctor
principal investigator · Changhai Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Tislelizumab

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