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
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
177 participants
Jul 1, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria10
- 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 Criteria11
- 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
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Interventions
Penpulimab 200mg IV D1 1 cycle every 21 days
Anlotinib 12mg/10mg P.O. QD D1-14 (12mg for body surface area ≥1.6m2, 10mg for body surface area ≤1.6m2) 1 cycle every 21 days
Nab-paclitaxel 125mg/m2 I.V. D1,8 1 cycle every 21 days
Gemcitabine 1.0g/m2 I.V. D1,8 1 cycle every 21 days
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06051851