Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for BRPC

NCT ID: NCT06573398

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2027-09-01

Brief Summary

This is a prospective, single-center, single-arm, phase II clinical study. The primary purpose of the study was to evaluate the efficacy and safety of radiotherapy with sequential albumin-bound paclitaxel + Gemcitabine chemotherapy + anti-PD-1 monoclonal antibody and Thymalfasin for borderline resectable pancreatic cancer, and to explore clinical indicators related to efficacy, further guiding subsequent individualized precise treatment.

Detailed Description

This is a prospective, single-center, single-arm, phase II clinical study. In this study, 20 patients with borderline resectable pancreatic cancer and without any prior treatment will be enrolled. After signing the informed consent form, patients will be screened to ensure they meet the eligibility criteria.Before surgery, eligible patients will receive 4 cycles of neoadjuvant therapy: Tislelizumab combined with AG regimen and SBRT and 13 weeks of Thymalfasin therapy; after 4 cycles, the efficacy will be evaluated and radical surgery will be performed on schedule. The postoperative treatment of patients will be jointly decided by clinical physicians and patients according to the actual conditions of clinical diagnosis and treatment.

The main observation indicator is the R0 resection rate after neoadjuvant therapy; Safety assessment: The safety will be assessed after each cycle of neoadjuvant therapy and at 30 days after the last dose; Event follow-up: The events will be followed once every 3 months during the first year after surgery, and once every 6 months during the second year after surgery.

Conditions

Carcinoma, Pancreatic Ductal

Study Design

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

Study Groups

CRT+PD-1 inhibitor+Thymalfasin

All eligible 20 subjects will receive a neoadjuvant therapy regimen of chemoradiotherapy combined with anti-PD-1 monoclonal antibody and Thymalfasin.

Group Type: EXPERIMENTAL

SBRT with Sequential AG regimen +Tislelizumab+Thymalfasin

Intervention Type: COMBINATION_PRODUCT

Stereotactic body radiation therapy (SBRT): 30 \~ 40 Gy/5f, Week 1, Day 1 \~ Day 5, 6-8 Gy/time, once a day; 3 weeks as a cycle, for 4 cycles Tislelizumab: 200 mg, i.v., single infusion, 21 days as a cycle for 4 cycles, on Day 1 of each treatment cycle; Thymalfasin: 4.8 mg, subcutaneous injection, twice a week, on Day 1 and Day 4 of each week during Weeks 1 \~ 13; Albumin-bound paclitaxel: 125 mg/m2, i.v., on Day 1 and Day 8 of each treatment cycle; Gemcitabine: 1000mg/m2, i.v., on Day 1 and Day 8 of each treatment cycle; After 4 cycles of preoperative neoadjuvant therapy, radical surgery will be evaluated by the MDT team within 2-4 weeks after completion of chemotherapy + immunotherapy.

Interventions

SBRT with Sequential AG regimen +Tislelizumab+Thymalfasin

Stereotactic body radiation therapy (SBRT): 30 \~ 40 Gy/5f, Week 1, Day 1 \~ Day 5, 6-8 Gy/time, once a day; 3 weeks as a cycle, for 4 cycles Tislelizumab: 200 mg, i.v., single infusion, 21 days as a cycle for 4 cycles, on Day 1 of each treatment cycle; Thymalfasin: 4.8 mg, subcutaneous injection, twice a week, on Day 1 and Day 4 of each week during Weeks 1 \~ 13; Albumin-bound paclitaxel: 125 mg/m2, i.v., on Day 1 and Day 8 of each treatment cycle; Gemcitabine: 1000mg/m2, i.v., on Day 1 and Day 8 of each treatment cycle; After 4 cycles of preoperative neoadjuvant therapy, radical surgery will be evaluated by the MDT team within 2-4 weeks after completion of chemotherapy + immunotherapy.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years, with ECOG score of 0 ~ 1;

2. Histologically or cytologically confirmed diagnosis of ductal adenocarcinoma of pancreas;

3. Classification as borderline resectable pancreatic cancer according to the NCCN Guidelines (2024 Edition);

4. Deemed suitable for neoadjuvant therapy following discussion by the MDT team of the study site;

5. Subjects must meet the following criteria for hematology test:

1. Neutrophil count ≥ 1.5 × 10^9/L

2. Hemoglobin ≥ 10 g/dL

3. Platelet count ≥ 100 × 10^9/L

6. Subjects must meet the following criteria for blood chemistry tests:

1. Total bilirubin ≤ 1.5 × upper limit of normal (ULN)

2. AST and ALT < 1.5 × ULN

3. Creatinine clearance ≥ 60 mL/min

4. Good coagulation, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN

7. Subjects of childbearing potential should take appropriate protective measures (contraceptive methods or other birth control methods) prior to enrollment and throughout the clinical study;

8. Has signed the informed consent form;

9. Capable of complying with the study protocol and follow-up procedures.

Exclusion Criteria

1. Prior systemic anti-tumor therapy;

2. Prior medical history of other tumors, except for cervical carcinoma in situ, treated squamous cell carcinoma or urothelial bladder carcinoma (Ta and TIS), or other malignant tumors that have received radical treatment (at least 5 years prior to enrollment);

3. Prior history of abdominal radiotherapy;

4. Subjects with active bacterial or fungal infection (≥ Grade 2 as per NCI-CTC, Version 3).

5. Subjects with HIV, HCV, or HBV infection, uncontrollable coronary artery disease or asthma, uncontrollable cerebrovascular disease or other diseases judged by the investigator to be ineligible for enrollment;

6. Subjects with autoimmune diseases or immunodeficiency and requiring treatment with immunosuppressive agents;

7. Pregnant or lactating women; women of childbearing potential must have a negative pregnancy test results within 7 days prior to enrollment;

8. Subjects with drug abuse/clinical/psychological/social factors that affect informed consent or study conduct;

9. Subjects who may be allergic to PD-1 monoclonal antibody immunotherapy drugs;

10. Patients who are scheduled to undergo or have previously undergone organ or bone marrow transplant;

11. Patients requiring treatment with systemic corticosteroids (at dose level > 10 mg/day prednisone efficacy) or other immunosuppressive drugs within 14 days prior to the first dose or during the study. However, enrollment is permitted if: In the absence of active autoimmune disease, patients are permitted to use topical or inhaled steroids, or adrenal hormone replacement therapy at dose level ≤ 10 mg/day prednisone efficacy;

12. Treatment with live vaccines within 28 days prior to the first dose; except for inactivated viral vaccines for seasonal influenza;

13. Active pulmonary tuberculosis;

14. Treatment with related drugs or medical technology affecting immunity within 6 months prior to the first dose (including but not limited to: thymopentin, thymalfasin, interferon, CAR-T therapy, etc.);

15. Patients with other conditions unsuitable for this clinical trial judged by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

JIABIN JIN

Associate Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Baiyong Shen, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Jiabin Jin, PhD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Central Contacts

Jiabin Jin, PhD

Role: CONTACT

jjb11501@rjh.com.cn

+86 18101870031

Other Identifiers

ZDX+PD-1+CRT-PDAC

Identifier Type: -

Identifier Source: org_study_id