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

NCT ID: NCT06080854

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-10
• Study Completion Date: 2026-06-06

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.

Conditions

Pancreatic Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Toripalimab

Intervention Type: DRUG

Toripalimab 240mg administered intravenously on Days 1 of every 3 weeks

Gemcitabine

Intervention Type: DRUG

Gemcitabine 1000 mg/m\^2 administered intravenously on Days 1 \& 8 of every 3 weeks

Nab paclitaxel

Intervention Type: DRUG

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

SBRT

Intervention Type: OTHER

SBRT Radiotherapy plan: Planning gross tumor volume (PGTV) 5Gy\*10 fractions, Planning target volume (PTV) 3Gy\*10 fractions

Interventions

Toripalimab

Toripalimab 240mg administered intravenously on Days 1 of every 3 weeks

Intervention Type: DRUG

Gemcitabine

Gemcitabine 1000 mg/m\^2 administered intravenously on Days 1 \& 8 of every 3 weeks

Intervention Type: DRUG

Nab paclitaxel

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

Intervention Type: DRUG

SBRT

SBRT Radiotherapy plan: Planning gross tumor volume (PGTV) 5Gy\*10 fractions, Planning target volume (PTV) 3Gy\*10 fractions

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: collaborator

Shanghai Changzheng Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

Xuzhou Central Hospital

OTHER

Sponsor Role: collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 36889321 (View on PubMed)

Other Identifiers

PRAG

Identifier Type: -

Identifier Source: org_study_id