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

Pancreatic Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06080854
• Other study ID #: PRAG
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 10, 2023
• Est. completion date: June 6, 2026

Study information

• Verified date: July 2023
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• 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: Not yet recruiting
• Enrollment: 108
• Est. completion date: June 6, 2026
• Est. primary completion date: June 6, 2025
• 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;

3. Pancreatic cancer confirmed by histology or cytology;

4. Potentially resectable pancreatic cancer documented by contrast enhanced CT (or MRI) scan;

5. 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.

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:
• Toripalimab
Toripalimab 240mg 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
Nab paclitaxel 125 mg/m^2 administered intravenously on Days 1 & 8 of every 3 weeks.

Other:
• SBRT
SBRT 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 (6)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Fudan University, Shanghai Changzheng Hospital, The First Affiliated Hospital of Soochow University, The First Affiliated Hospital with Nanjing Medical University, Xuzhou Central Hospital

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	R0 resection rate	R0 resection rate	2 years
Secondary	os	OS is defined as the time from randomization to death due to any cause.	3 years
Secondary	pfs	PFS is defined as the time from the first day of randomization to the date of first record of disease progression or death.	3 years
Secondary	dcr	DCR including CR, PR, and SD	3 years
Secondary	Adverse Events	Adverse event (AE)?Serious adverse event (SAE)	3 years