Other Clinical Trial - Penpulimab Combined With Anlotinib & Nab-paclitaxel

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This study is a multi-center, open-label, randomized controlled Phase II clinical study to evaluate the efficacy and safety of penpulimab in combination with anlotinib and AG regimen in the first-line treatment of advanced metastatic pancreatic cancer, and to explore the clinical indicators related to efficacy to guide the individualized treatment. Trial group: Nab-paclitaxel 125mg/m2 I.V. D1,8 Gemcitabine 1.0g/m2 I.V. D1,8 Penpulimab 200mg IV D1 Anlotinib 12mg/10mg P.O. QD D1-14 (12mg for body surface area ≥1.6m2, 10mg for body surface area ≤1.6m2) Control group: Nab-paclitaxel 125mg/m2 I.V. D1,8 Gemcitabine 1.0g/m2 I.V. D1,8 1 cycle every 21 days Efficacy assessments will be performed every 2 cycles for the first 8 cycles of treatment. If treatment exceeds 8 cycles (24 weeks) in the trial group, maintenance therapy with anlotinib + PD1 and efficacy assessment every 2 cycles; in the control group, efficacy assessment every 2 cycles. Patient with disease control (CR+PR+SD) and tolerable adverse events were continued on the drug until discontinuation of the drug if efficacy was evaluated as disease progression (PD), if an intolerable adverse event occurred, or if the investigator deemed it unsuitable for the patient to continue on the treatment. Efficacy Indicators Primary endpoint: median progression-free survival (mPFS) Secondary endpoint: objective response rate (ORR), disease control rate (DCR), median overall survival (mOS), safety; potential biological indicators for predicting efficacy (tumor tissue NGS assay, ctDNA, mRNA, and various immune cytokines in peripheral blood, etc.) Safety evaluation indexes: Observe the presence or absence of clinical adverse events such as myelosuppression, nausea, vomiting, liver damage, skin reactions (e.g., rash), pneumonitis, hypertension, proteinuria, fatigue, and nausea, etc., which are graded according to NCI criteria. ;

Study Design

Related Conditions & MeSH terms

Pancreatic Adenocarcinoma Metastatic
Pancreatic Neoplasms

Clinical Trial Details

NCT number	NCT06051851
Study type	Interventional
Source	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Contact	Juan Du
Phone	+0086-13951826526
Email	dujuanglyy@163.com
Status	Recruiting
Phase	Phase 2
Start date	July 1, 2023
Completion date	July 1, 2026

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT06006728` - Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy
Terminated	`NCT03213626` - Cabozantinib and Erlotinib for Patients With EGFR and c-Met Co-expressing Metastatic Pancreatic Adenocarcinoma	Phase 2
Recruiting	`NCT05077800` - FOLFIRINOX + 9-Ing-41 + Losartan In Pancreatic Cancer	Phase 2
Completed	`NCT01715142` - Effect on Tumor Perfusion of a Chemotherapy Combining Gemcitabine and Nab-paclitaxel (Abraxane) in Pancreatic Cancer	Early Phase 1
Completed	`NCT02179970` - To Assess the Safety of Continuous IV Administration of Plerixafor in Patients With Advanced Pancreatic, Ovarian and Colorectal Cancers	Phase 1
Completed	`NCT02195180` - Efficacy and Safety of L-asparaginase Encapsulated in RBC Combined With Gemcitabine or FOLFOX in 2nd Line for Progressive Metastatic Pancreatic Carcinoma	Phase 2
Recruiting	`NCT03633734` - Efficacy Evaluation of Sequential Treatment With AG and Modified Folfirinox in Metastatic Pancreatic Adenocarcinoma	Phase 1/Phase 2
Completed	`NCT03529175` - Scheduling Nab-paclitaxel With Gemcitabine	Phase 2
Recruiting	`NCT05360264` - tailOred dRug repurposIng of dEcitabine in KRAS-dependeNt refracTory pAncreaTic cancEr	Phase 2
Recruiting	`NCT04150042` - SHARON: A Clinical Trial for Metastatic Cancer With a BRCA or PALB2 Mutation Using Chemotherapy and Patients' Own Stem Cells	Phase 1
Withdrawn	`NCT03127124` - QUILT-2.022 NANT-008 in Combination w/ 5-fluorouracil, Bevacizumab, Leucovorin & Oxaliplatin in Subjects With Pancreatic Cancer	Phase 1/Phase 2
Not yet recruiting	`NCT06076837` - The Seven Trial: Exploiting the Unfolded Protein Response	Phase 1
Recruiting	`NCT06396637` - PD-1 Antibody and Sapropterin Dihydrochloride in Patients With PDAC	Phase 2
Completed	`NCT01053013` - Open-Label Phase 2 Efficacy Trial of Cancer Macrobeads in Patients With Treatment-Resistant Pancreatic/Colorectal Cancer	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms