Clinical trial · Interventional
Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine as First-line Treatment for Advanced Metastatic Pancreatic Cancer
Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine (PAAG) as First-line Treatment for Advanced Metastatic Pancreatic Cancer: a Prospective, Multicenter, Single-arm, Phase 2 Study
- 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 multi-center, open-label, randomized controlled Phase II clinical study to observe and evaluate the efficacy and safety of Penpulimab combined with Anlotinib and Nab-paclitaxel plus Gemcitabine (PAAG ) versus AG first-line treatment in patients 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 Adenocarcinoma Metastatic | — | UNRESOLVED | — |
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 (2)
- type
- EXPERIMENTAL
- label
- Trial group
- description
- penpulimab in combination with anlotinib and AG regimen in the first-line treatment of advanced metastatic pancreatic cancer
- interventionNames
- Drug: Penpulimab
- Drug: Anlotinib
- Drug: Nab paclitaxel
- Drug: Gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- AG regimen in the first-line treatment of advanced metastatic pancreatic cancer
- interventionNames
- Drug: Nab paclitaxel
- Drug: Gemcitabine
Primary outcomes (1)
- measure
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 (0)
Data not yet available