Concurrent Chemoradiotherapy Combined With Immunotherapy in Patients With Potentially Resectable Pancreatic Cancer

NCT05634564 | Unknown Phase 2

• 1 other identifier: CRP-PC
• Study Type: interventional
• Target: 62
• 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 (1)

• Objective Response Rate (ORR)

  RECIST Version 1.1

  Up to 2 years

Secondary Outcomes (6)

• R0 resection rate

  Up to 1 years

• Median Progression Free Survival (mPFS)

  Up to 2 years

• Median Overall survival (mOS)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Pathological grade of tumor tissue after neoadjuvant therapy

  Up to 1 years

Study Arms (1)

Concurrent radiochemotherapy combined with immunotherapy

EXPERIMENTAL

Participants will receive tislelizumab 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: Tislelizumab; Drug: Gemcitabine; Drug: Nab paclitaxel; Radiation: Hypofractionated radiotherapy with simultaneous integrated boost

Interventions

Tislelizumab DRUG

Tislelizumab 200mg 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

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

Concurrent radiochemotherapy combined with immunotherapy

Hypofractionated radiotherapy with simultaneous integrated boost RADIATION

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； 2. Eastern Cooperative Oncology Group (ECOG) score of 0-1; 2. Pancreatic cancer confirmed by histology or cytology; 3. Potentially resectable pancreatic cancer documented by contrast enhanced CT (or MRI) scan; 4. Hematological indexes: Neutrophil count \>= 1.5 x 10\^9/L Hemoglobin \>= 10g / dl Platelet count \>= 100 x 10\^9 / L 5. 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: 7. Signed informed consent; 8. 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

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (1)

• Ni J, Sun Y, Cheng H, Bai X, Tong F, Zhang X, Wang X, Mao L, Li G, Shen S, Kong W, He J, Li A, Chen J, Tang M, Chen B, Li Q, Gu Q, Lu Z, Chen D, Sha H, Liu B, Qiu Y, Du J. Tislelizumab and hypofractionated radiotherapy plus nab-paclitaxel/gemcitabine as conversion therapy for BRPC/LAPC: A Phase II trial with dynamic biomarker monitoring. Clin Cancer Res. 2025 Dec 1. doi: 10.1158/1078-0432.CCR-25-2461. Online ahead of print.

  PMID: 41324566 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

tislelizumab; 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

Central Study Contacts

Juan Du, MD

CONTACT

86-25-83106666; dujuanglyy@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 2, 2022
• Study Start: June 1, 2020
• Primary Completion: April 1, 2023
• Study Completion: December 31, 2023
• Last Updated: December 5, 2022

Record last verified: 2022-12

Locations

CN (1)