A Study of Penpulimab and Anlotinib Plus Nab-paclitaxel and Gemcitabine for Metastatic Pancreatic Cancer. (PAAG)

Nanjing University

Status and phase

Completed

Phase 2

Conditions

Pancreatic Neoplasms

Treatments

Drug: Anlotinib

Drug: Gemcitabine

Drug: Nab paclitaxel

Drug: Penpulimab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05493995

2022-351-02

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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