A Study of Penpulimab and Anlotinib Plus Nab-paclitaxel and Gemcitabine for Metastatic Pancreatic Cancer.
- Conditions
- Pancreatic Neoplasms
- Interventions
- Registration Number
- NCT05493995
- Lead Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Brief 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 Metastatic Pancreatic Cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Penpulimab+Anlotinib+Nab-paclitaxel+Gemcitabine Nab paclitaxel - Penpulimab+Anlotinib+Nab-paclitaxel+Gemcitabine Anlotinib - Penpulimab+Anlotinib+Nab-paclitaxel+Gemcitabine Gemcitabine - Penpulimab+Anlotinib+Nab-paclitaxel+Gemcitabine Penpulimab -
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) up to 3 years Objective response rate is defined as the percentage of subjects whose best response was complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors Criteria(RECIST v1.1).
Disease Control Rate (DCR) up to 3 years Disease control rate is defined as the percentage of subjects whose best response was CR, PR or stable disease (SD) according to the RECIST v1.1.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) up to 3 years Overall Survival (OS) (median) is determined using the number of months measured from the initial date of treatment to the recorded date of death of participants.
Progression-free survival (PFS) up to 3 years Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Trial Locations
- Locations (1)
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China