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

Pancreatic Neoplasms Clinical Trial

— PAAG  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05493995
• Other study ID #: 2022-351-02
• Status: Completed
• Phase: Phase 2
• Start date: July 21, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2024
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Drug:
• Penpulimab
Penpulimab 200 mg administered intravenously every 3 weeks.
• Anlotinib
12mg, continuous oral 2 weeks stop for 1 week, 21 days for a treatment cycle.
• Nab paclitaxel
125mg/m^2,administered intravenously on days 1 and 8 of every 21-day cycle.
• Gemcitabine
1.0g/m^2, administered intravenously on days 1 and 8 of every 21-day cycle.

Locations

Country	Name	City	State
China	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	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).	up to 3 years
Primary	Disease Control Rate (DCR)	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.	up to 3 years
Secondary	Overall Survival (OS)	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.	up to 3 years
Secondary	Progression-free survival (PFS)	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.	up to 3 years