A Phase 2, Randomized, Multicenter Study of Penpulimab and Anlotinib in Combination With Nab-paclitaxel Plus Gemcitabine as First-line Therapy in Patients (Pts) With Advanced Metastatic Pancreatic Cancer: PAAG.

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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 Advanced Metastatic Pancreatic Cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Collaborator: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Treatments: Gemcitabine; Paclitaxel

Criteria

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