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

Phase 2

Not yet recruiting

• Conditions: Pancreatic Carcinoma
• Interventions: Drug: Toripalimab; Drug: Gemcitabine; Drug: Nab paclitaxel; Other: SBRT

• Registration Number: NCT06080854
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Detailed 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.

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-10-06
• Last Update Submitted: 2023-10-06
• Study First Posted: 2023-10-12
• Last Update Posted: 2023-10-12
• Study Start: 2023-11-10
• Primary Completion: 2025-06-06
• Study Completion: 2026-06-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Concurrent radiochemotherapy combined with immunotherapy	SBRT	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.
Concurrent radiochemotherapy combined with immunotherapy	Nab paclitaxel	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.
Concurrent radiochemotherapy combined with immunotherapy	Toripalimab	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.
Concurrent radiochemotherapy combined with immunotherapy	Gemcitabine	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.

Primary Outcome Measures

Name	Time	Method
ORR	2 years	RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1 RECIST Version 1.1
R0 resection rate	2 years	R0 resection rate

Secondary Outcome Measures

Name	Time	Method
Adverse Events	3 years	Adverse event (AE)、Serious adverse event (SAE)
os	3 years	OS is defined as the time from randomization to death due to any cause.
pfs	3 years	PFS is defined as the time from the first day of randomization to the date of first record of disease progression or death.
dcr	3 years	DCR including CR, PR, and SD

Trial Locations

Locations (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China