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

Trial ID: NCT06051851

Interventional - Phase 2 - Unknown status

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

• Pancreatic Adenocarcinoma Metastatic

Interventions

• Penpulimab
• Anlotinib
• Nab paclitaxel
• Gemcitabine

Eligibility

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

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Source: ClinicalTrials.gov

Search more clinical trials on myTomorrows