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

Pancreatic Carcinoma Clinical Trial

Official title:

Efficacy and Safety of Concurrent Chemoradiotherapy Combined With Immunotherapy in Patients With Potentially Resectable Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05634564
• Other study ID #: CRP-PC
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Juan Du, MD
• Phone: 86-25-83106666
• Email: dujuanglyy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Due to the hidden onset and rapid progression of pancreatic cancer, most patients are already locally advanced or have distant metastasis at the time of diagnosis and lose the opportunity for surgery. Even among operable patients, about 50% will have recurrence and metastasis one year after surgery. Therefore, more and more evidence supports neoadjuvant therapy for patients with high risk factors for resectable pancreatic cancer, and conversion therapy followed by surgery for patients with borderline resectable and locally advanced pancreatic cancer. Therefore, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: December 31, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

6. 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.

Exclusion Criteria:

1. Have received systematic anti-tumor treatment.

2. 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).

3. Active bacterial or fungal infection (> = level 2 of National Cancer Institute Common Toxicity Criteria (NCI-CTC), Version 3.0).

4. 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.

5. Autoimmune diseases or immune defects who are treated with immunosuppressive drugs.

6. Pregnant and lactating women. Pregnant women of childbearing age must be tested negative within 7 days before entering the group.

7. Drug abuse, clinical or psychological or social factors make informed consent or research implementation affected.

8. Allergic to programmed cell death protein-1 (PD-1) monoclonal antibody immunotherapy drugs.

Related Conditions & MeSH terms

• Pancreatic Carcinoma
• Pancreatic Neoplasms

Intervention

Drug:
• Tislelizumab
Tislelizumab 200mg administered intravenously on Days 1 of every 3 weeks.
• Gemcitabine
Gemcitabine 1000 mg/m^2 administered intravenously on Days 1 & 8 of every 3 weeks.
• Nab paclitaxel
Gemcitabine 125 mg/m^2 administered intravenously on Days 1 & 8 of every 3 weeks.

Radiation:
• Hypofractionated radiotherapy with simultaneous integrated boost
Radiotherapy plan: Planning gross tumor volume (PGTV) 5Gy*10 fractions, Planning target volume (PTV) 3Gy*10 fractions.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	RECIST Version 1.1	Up to 2 years
Secondary	R0 resection rate	R0 resection rate	Up to 1 years
Secondary	Median Progression Free Survival (mPFS)	RECIST Version 1.1	Up to 2 years
Secondary	Median Overall survival (mOS)	RECIST Version 1.1	Up to 2 years
Secondary	Disease control rate (DCR)	RECIST Version 1.1	Up to 2 years
Secondary	Pathological grade of tumor tissue after neoadjuvant therapy	Pathological grade of tumor tissue after neoadjuvant therapy	Up to 1 years
Secondary	Adverse Events	Adverse event (AE)?Serious adverse event (SAE)	Up to 2 years