AG Combined With Immunotherapy and SBRT in Patients With Potentially Resectable Pancreatic Cancer

NCT06080854 | Not Yet Recruiting Phase 2

• 1 other identifier: PRAG
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with immunotherapy in patients with potentially resectable pancreatic cancer.

Conditions

Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (2)

• ORR

  RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1

  2 years

• R0 resection rate

  R0 resection rate

  2 years

Secondary Outcomes (4)

• os

  3 years

• pfs

  3 years

• dcr

  3 years

• Adverse Events

  3 years

Study Arms (1)

Concurrent radiochemotherapy combined with immunotherapy

EXPERIMENTAL

Participants will receive toripalimab plus gemcitabine and nab-paclitaxel in cycles of 21 days. Non-progressors will plus concurrent radiotherapy during the 3rd cycle of chemotherapy. After 4-6 cycles treatment, Multiple disciplinary team (MDT) will evaluate whether to undergo radical surgery.

Drug: Toripalimab; Drug: Gemcitabine; Drug: Nab paclitaxel; Other: SBRT

Interventions

Toripalimab DRUG

Toripalimab 240mg administered intravenously on Days 1 of every 3 weeks

Concurrent radiochemotherapy combined with immunotherapy

Gemcitabine DRUG

Gemcitabine 1000 mg/m\^2 administered intravenously on Days 1 \& 8 of every 3 weeks

Concurrent radiochemotherapy combined with immunotherapy

Nab paclitaxel DRUG

Nab paclitaxel 125 mg/m\^2 administered intravenously on Days 1 \& 8 of every 3 weeks.

Concurrent radiochemotherapy combined with immunotherapy

SBRT OTHER

SBRT Radiotherapy plan: Planning gross tumor volume (PGTV) 5Gy\*10 fractions, Planning target volume (PTV) 3Gy\*10 fractions

Concurrent radiochemotherapy combined with immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18 years；
• Eastern Cooperative Oncology Group (ECOG) score of 0-1;
• Pancreatic cancer confirmed by histology or cytology;
• Potentially resectable pancreatic cancer documented by contrast enhanced CT (or MRI) scan;
• Hematological indexes: Neutrophil count \>= 1.5 x 10\^9/L Hemoglobin \>= 10g / dl Platelet count \>= 100 x 10\^9/L; Biochemical indicators: Total bilirubin \<= 1.5 x upper limit of normal value (ULN); Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \< 1.5 x ULN; Creatinine clearance rate \>= 60ml / min.
• Participants of childbearing age need to take appropriate protective measures (contraceptive measures or other methods of birth control) before entering the group and during the test;
• Signed informed consent;
• Follow the protocol and follow-up procedures.

You may not qualify if:

• Have received systematic anti-tumor treatment.
• Previous history of other tumors, except for cervical cancer in situ, treated squamous cell carcinoma or bladder epithelial tumor (TA and TIS) or other malignant tumors that have received radical treatment (at least 5 years before enrollment).
• Active bacterial or fungal infection (\> = level 2 of National Cancer Institute Common Toxicity Criteria (NCI-CTC), Version 3.0).
• Human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV) infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases considered by researchers to be out of the group.
• Autoimmune diseases or immune defects who are treated with immunosuppressive drugs.
• Pregnant and lactating women. Pregnant women of childbearing age must be tested negative within 7 days before entering the group.
• Drug abuse, clinical or psychological or social factors make informed consent or research implementation affected.
• Allergic to programmed cell death protein-1 (PD-1) monoclonal antibody immunotherapy drugs.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Fudan University: collaborator
• Shanghai Changzheng Hospital: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• Xuzhou Central Hospital: collaborator

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

Related Publications (1)

• Du J, Lu C, Mao L, Zhu Y, Kong W, Shen S, Tang M, Bao S, Cheng H, Li G, Chen J, Li Q, He J, Li A, Qiu X, Gu Q, Chen D, Qi C, Song Y, Qian X, Wang L, Qiu Y, Liu B. PD-1 blockade plus chemoradiotherapy as preoperative therapy for patients with BRPC/LAPC: A biomolecular exploratory, phase II trial. Cell Rep Med. 2023 Mar 21;4(3):100972. doi: 10.1016/j.xcrm.2023.100972. Epub 2023 Mar 7.

  PMID: 36889321 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

toripalimab; Gemcitabine; Taxes

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: October 12, 2023
• Study Start: November 10, 2023
• Primary Completion: June 6, 2025
• Study Completion (Estimated): June 6, 2026
• Last Updated: October 12, 2023

Record last verified: 2023-07

Locations

CN (1)