Clinical trial · Interventional
Tislelizumab With Anlotinib and Chemotherapy for Second-line Treatment of Pancreatic Cancer
A Prospective, One-arm, Phase II Clinical Study of Tislelizumab Combined With Anlotinib and Investigator-selected Chemotherapy for Second-line Treatment of Advanced or Metastatic Pancreatic Cancer: a
NCT05681390CI-TRIAL-00067038unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tislelizumab Combined With Anlotinib and Chemotherapy
- description
- Tislelizumab iv drip, every 3 weeks; Anlotinib, oral,once a day; chemotherapy will be choiced by investigator according guildline.
- interventionNames
- Drug: Tislelizumab
Primary outcomes (1)
- measure
- MedianProgression free survival(mPFS)
- timeFrame
- from enrollment to disease progression or death from any cause, up to 24 months
- description
- assessment by RECIST v1.1,at end of per 2 treatment cycles(each cycle is 21 days)
Secondary outcomes (3)
- measure
- objective response rate(ORR)
- timeFrame
- from enrollment to disease progression or death from any cause,up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.