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

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05634564
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 43
• Patients Per Site Per Month: 1.4

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: Tislelizumab; Drug: Gemcitabine; Drug: Nab paclitaxel; Radiation: Hypofractionated radiotherapy with simultaneous integrated boost	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: 62 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Concurrent Chemoradiotherapy Combined With Immunotherapy in Patients With Potentially Resectable Pancreatic Cancer
• Actual Study Start Date: Jun 1, 2020
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Concurrent radiochemotherapy combined with immunotherapy Participants will receive tislelizumab 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: Tislelizumab; Tislelizumab 200mg 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; 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.

Outcome Measures

Primary Outcome Measures

1. Objective Response Rate (ORR) [Up to 2 years]

   RECIST Version 1.1

Secondary Outcome Measures

1. R0 resection rate [Up to 1 years]

   R0 resection rate

2. Median Progression Free Survival (mPFS) [Up to 2 years]

   RECIST Version 1.1

3. Median Overall survival (mOS) [Up to 2 years]

   RECIST Version 1.1

4. Disease control rate (DCR) [Up to 2 years]

   RECIST Version 1.1

5. Pathological grade of tumor tissue after neoadjuvant therapy [Up to 1 years]

   Pathological grade of tumor tissue after neoadjuvant therapy

6. Adverse Events [Up to 2 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; 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.

2. 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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Du Juan, Clinical Professor, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• ClinicalTrials.gov Identifier: NCT05634564
• Other Study ID Numbers: CRP-PC
• First Posted: Dec 2, 2022
• Last Update Posted: Dec 5, 2022
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pancreatic Neoplasms; Gemcitabine; Paclitaxel

Study Results

No Results Posted as of Dec 5, 2022