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

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06080854
• Collaborator: The First Affiliated Hospital with Nanjing Medical University (Other), Fudan University (Other), Shanghai Changzheng Hospital (Other), The First Affiliated Hospital of Soochow University (Other), Xuzhou Central Hospital (Other)
• Enrollment: 108
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 30.9
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Carcinoma	Drug: Toripalimab; Drug: Gemcitabine; Drug: Nab paclitaxel; Other: SBRT	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 108 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of AG Combined With Immunotherapy and SBRT in Patients With Potentially Resectable Pancreatic Cancer
• Anticipated Study Start Date: Nov 10, 2023
• Anticipated Primary Completion Date: Jun 6, 2025
• Anticipated Study Completion Date: Jun 6, 2026

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Concurrent radiochemotherapy combined with immunotherapy 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; Toripalimab 240mg administered intravenously on Days 1 of every 3 weeks; Drug: Gemcitabine; Gemcitabine 1000 mg/m^2 administered intravenously on Days 1 & 8 of every 3 weeks; Drug: 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

Outcome Measures

Primary Outcome Measures

1. 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

2. R0 resection rate [2 years]

   R0 resection rate

Secondary Outcome Measures

1. os [3 years]

   OS is defined as the time from randomization to death due to any cause.

2. 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.

3. dcr [3 years]

   DCR including CR, PR, and SD

4. Adverse Events [3 years]

   Adverse event (AE)、Serious adverse event (SAE)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu	China	210008

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• ClinicalTrials.gov Identifier: NCT06080854
• Other Study ID Numbers: PRAG
• First Posted: Oct 12, 2023
• Last Update Posted: Oct 12, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Pancreatic Neoplasms; Paclitaxel; Gemcitabine

Study Results

No Results Posted as of Oct 12, 2023