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.

2022-351-02

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.

2022-07-21

2024-05-01

2024-05-01

Completed

Early phase I

66

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 66, 'type': 'ACTUAL'}}

2024-05-09