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RecruitingNCT05681390Updated Jun 9, 2023

Tislelizumab With Anlotinib and Chemotherapy for Second-line Treatment of Pancreatic Cancer

A Phase 2 interventional study of Tislelizumab in Pancreatic Neoplasms, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-06-09.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 9 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a prospective, one-arm, phase II clinical study of Tislelizumab Combined With Anlotinib and Chemotherapy for Second-line Treatment of Advanced or Metastatic Pancreatic Cancer

Read the detailed description

This is a single-arm, open-label, clinical trial of tislelizumab in combination with anlotinib and investigator-selected chemotherapy for second-line treatment of patients with advanced or metastatic pancreatic cancer. Patients with histopathologically or cytologically confirmed unresectable, recurrent or metastatic pancreatic cancer are planned to be recruited. Systemic medical antineoplastic therapy previously treated with first-line chemotherapy, meeting the inclusion and exclusion criteria of this study, and giving tislelizumab and anlotinib in combination with investigator 's choice of second-line chemotherapy regimen

02

Conditions studied

  • Pancreatic Neoplasms

Keywords

  • Advanced
  • second-line treatment
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's planned enrollment of 30 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Advanced or metastatic pancreatic adenocarcinoma diagnosed by pathology;
  • Previously received a standard first-line chemotherapy regimen of pancreatic cancer
  • Age ≥ 18 and≤ 75 years old;
  • Expected survival ≥ 3 months;
  • ECOG score 0-1;
  • Child-Pugh score \< 8;
  • There is at least one measurable tumor lesion: the long diameter is ≥10 mm, and the short diameter of lymph nodes is ≥15 mm;
  • The results of liver and kidney function and blood routine examination within 1 week before enrollment meet the following conditions:

Neutrophils (ANC) ≥ 1.5×109/L, platelets (PLT) ≥ 80×109/L, hemoglobin (HGB) ≥ 80g/L; Serum creatinine (Cr) ≤ 1.5 × upper limit of normal value; total bilirubin (TBIL) ≤ 2.5 × upper limit of normal value, Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤2.5× upper limit of normal value;

  • The patient voluntarily participated in this study and signed the informed consent form.

Exclusion criteria

Exclusion Criteria:

  • Received other immunotherapy previously(including immune checkpoint inhibitor PD-1/PDL1 and other immune checkpoint inhibitors) and/or anti-angiogenic drugs (including anti-VEGFR monoclonal antibody and anti-angiogenic small molecule kinase inhibitors) ; Known to be severely allergic to the drugs used in the study of tislelizumab and anlotinib;
  • Patients with obstructive jaundice who cannot reach TBIL ≤ 2.5 times the upper limit of normal value after surgical intervention;
  • Patients with biliary obstruction that may occur or worsen within 4 to 6 weeks;
  • Obvious blood coagulation disorder, active bleeding and bleeding tendency;
  • There is a history of other malignant tumors within 5 years (adequately treated skin basal cell carcinoma, cervical in situ);
  • Interstitial pneumonia or pulmonary fibrosis;
  • Uncontrollable pleural effusion or ascites;
  • Severe uncontrolled medical diseases, acute infections, recent history of myocardial infarction (within 3 months);
  • During pregnancy or breastfeeding, and those who refuse to take appropriate contraceptive measures during the test;
  • Patients judged by the investigator to be inappropriate to participate in this study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Tislelizumab Combined With Anlotinib and Chemotherapy

    Tislelizumab iv drip, every 3 weeks; Anlotinib, oral,once a day; chemotherapy will be choiced by investigator according guildline.

    Drug: Tislelizumab

Interventions

  • DrugTislelizumab

    Tislelizumab 200mg iv drip, d1, Q3W;Anlotinib tablet : 10mg, PO, QD; Chemotherapy: selected by investigator following CSCO or NCCN pancreatic adenocarcinoma guideline; Tislelizumab and Anlotinib continue unless disease progression or intolerance to toxicity, chemotherapy continue upto 8 cycles unless disease progression or intolerance to toxicity

    Also known as: Beigene

06

What researchers measure

Primary outcomes

  1. MedianProgression free survival(mPFS)

    assessment by RECIST v1.1,at end of per 2 treatment cycles(each cycle is 21 days)

    Time frame: from enrollment to disease progression or death from any cause, up to 24 months

Secondary outcomes

  1. objective response rate(ORR)

    assessment by RECIST v1.1,at end of per 2 treatment cycles(each cycle is 21 days)

    Time frame: from enrollment to disease progression or death from any cause,up to 24 months

  2. Median Overall Survival

    document and assessment on baseline, at end of 2 treatment cycles(each cycle is 21 days)

    Time frame: from enrollment to death from any cause,up to 24 months

  3. disease control rate(DCR)

    document and assessment on baseline, at end of 2 treatment cycles(each cycle is 21 days)

    Time frame: up to 24 months

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Xian Jiaotong University
    Xi'an, Shanxi 710004, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05681390
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Responsible party
Sponsor
First posted
Jan 12, 2023
Start date
Jan 1, 2023
Primary completion
Dec 31, 2024 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Jun 9, 2023

Study contacts

Xuyuan Dong, Doctor
Contact
2005dongxuyuan@163.com
86-15332304217
EnXiao Li, Doctor
principal investigator · First hospital of Xi'an Jiaotong University

Oversight

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

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