Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine as First-line Treatment for Advanced Metastatic Pancreatic Cancer

NCT06051851 | Recruiting Phase 2

• 1 other identifier: 2023-289-01
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, open-label， randomized controlled Phase II clinical study to observe and evaluate the efficacy and safety of Penpulimab combined with Anlotinib and Nab-paclitaxel plus Gemcitabine (PAAG ) versus AG first-line treatment in patients with metastatic pancreatic cancer.

Conditions

Pancreatic Adenocarcinoma Metastatic

Keywords

advanced metastatic pancreatic cancer; Chemotherapy; immunotherapy; Targeted Therapy

Outcome Measures

Primary Outcomes (1)

• 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 1 years

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  up to 1 years

• Disease Control Rate (DCR)

  up to 1 years

• Overall Survival (OS)

  up to 2 years

Study Arms (2)

Trial group

EXPERIMENTAL

penpulimab in combination with anlotinib and AG regimen in the first-line treatment of advanced metastatic pancreatic cancer

Drug: Penpulimab; Drug: Anlotinib; Drug: Nab paclitaxel; Drug: Gemcitabine

Control group

ACTIVE COMPARATOR

AG regimen in the first-line treatment of advanced metastatic pancreatic cancer

Drug: Nab paclitaxel; Drug: Gemcitabine

Interventions

Penpulimab DRUG

Penpulimab 200mg IV D1 1 cycle every 21 days

Trial group

Anlotinib DRUG

Anlotinib 12mg/10mg P.O. QD D1-14 (12mg for body surface area ≥1.6m2, 10mg for body surface area ≤1.6m2) 1 cycle every 21 days

Trial group

Nab paclitaxel DRUG

Nab-paclitaxel 125mg/m2 I.V. D1,8 1 cycle every 21 days

Control group; Trial group

Gemcitabine DRUG

Gemcitabine 1.0g/m2 I.V. D1,8 1 cycle every 21 days

Control group; Trial group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Interventions

penpulimab; anlotinib; Taxes; Gemcitabine

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Juan Du

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Du

CONTACT

+0086-13951826526; dujuanglyy@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)