Clinical trial · Interventional
A Study of Penpulimab and Anlotinib Plus Nab-paclitaxel and Gemcitabine for Metastatic Pancreatic Cancer.
A Multicenter Study of Penpulimab and Anlotinib in Combination With Nab-paclitaxel Plus Gemcitabine as First-line Therapy in Patients (Pts) With Metastatic Pancreatic Cancer: PAAG.
NCT05493995CI-TRIAL-00077003PAAGcompletedPhase 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)
It is a trial to assess the efficacy and safety of Penpulimab and Anlotinib in Combination With Nab-paclitaxel Plus Gemcitabine as first-line Therapy in Patients (Pts) With 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Nab paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Penpulimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Penpulimab+Anlotinib+Nab-paclitaxel+Gemcitabine
- interventionNames
- Drug: Penpulimab
- Drug: Anlotinib
- Drug: Nab paclitaxel
- Drug: Gemcitabine
Primary outcomes (2)
- measure
- Objective Response Rate (ORR)
- timeFrame
- up to 3 years
- description
- Objective response rate is defined as the percentage of subjects whose best response was complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors Criteria(RECIST v1.1).
- measure
- Disease Control Rate (DCR)
- timeFrame
- up to 3 years
- description
- Disease control rate is defined as the percentage of subjects whose best response was CR, PR or stable disease (SD) according to the RECIST v1.1.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ages ≥18 years,ECOG ≤ 2,Estimated survival time \> 3 months * Histologically or Cytologically confirmed metastatic pancreatic adenocarcinoma * Based on Response Evaluation Criteria In Solid Tumors (RECIST1.1), there should be at least one measurable lesion * Patients have never received systematical anti-cancer therapy * Laboratory examination meets the following requirements:White blood cell (WBC) ≥3.0×109/L; absolute neutrophil count (ANC) ≥1.5×109/L; Hemoglobin (HB) ≥90g/L; platelet count(PLT) ≥75×109/L; Total bilirubin (TBIL) ≤1.5× normal upper limit (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤2.5×ULN, if accompanied by liver metastasis, ALT and AST≤5×ULN; Serum creatinine (Cr) ≤1×ULN or creatinine clearance (CCr)≥50ml/min; * Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) \> 50% * Patients of childbearing age should take appropriate protective measures before enrollment and during the trial * Volunteer to join the study, sign the informed consent, have good compliance, and cooperate with follow-up * Ability to follow the study protocol and follow-up procedures. Exclusion Criteria: * Patients have ever received any systematical anti-cancer therapy in the past * Patients who participated in other clinical trials in the past 4 weeks * According to the investigator, patients who surgically available or potentially treatable(Patients who voluntarily give up surgical treatment can be enrolled after evaluation by the investigator) * Patients with moderate ascites requiring drainage * Patients with CNS metastases and/or carcinomatous meningitis * Patients with history of other primary malignancies except: 1) complete remission before enrollment for at least 2 years and requiring no additional treatment during the study period; 2) Adequately treated non-melanoma skin cancer or lentiform malignancy with no evidence of disease recurrence; 3) Adequately treated carcinoma in situ with no evidence of disease recurrence; * Patients with autoimmune disease or immune deficiency who are treated with immunosuppressive drugs * Patients with bleeding tendency. * Pregnant or lactating women. * Drug abuse, clinical or psychological or social factors that impact informed consent or the conduct of the study * Patients who may be allergic to PD-1 monoclonal antibody, anlotinib, albumin-bound paclitaxel and gemcitabine
References
Publications (1)
- DERIVEDSha H, Tong F, Ni J, Sun Y, Zhu Y, Qi L, Li X, Li W, Yang Y, Gu Q, Zhang X, Wang X, Zhu C, Chen D, Liu B, Du J. First-line penpulimab (an anti-PD1 antibody) and anlotinib (an angiogenesis inhibitor) with nab-paclitaxel/gemcitabine (PAAG) in metastatic pancreatic cancer: a prospective, multicentre, biomolecular exploratory, phase II trial. Signal Transduct Target Ther. 2024 Jun 7;9(1):143. doi: 10.1038/s41392-024-01857-6. PMID 38844468