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

NCT06573398 | Not Yet Recruiting Phase 2

• 1 other identifier: ZDX+PD-1+CRT-PDAC
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carcinoma, Pancreatic Ductal

Keywords

borderline resectable; thymalfasin; radiotherapy; chemotherapy; PD-1 inhibitor; pancreatic ductal adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• R0 resection rate

  Defined as the proportion of patients in the ITT population who undergo R0 resection following neoadjuvant therapy among patients undergoing surgery.

  within 10 days after surgery

Secondary Outcomes (10)

• Tumor regression grade (TRG)

  within 10 days after surgery

• Pathologic complete response (pCR) rate

  within 10 days after surgery

• Median progression-free survival (mPFS)

  24 months

• Median overall survival (mOS)

  24 months

• Major pathologic response (MPR) rate

  within 10 days after surgery

Other Outcomes (5)

• The expression of CD68

  up to 3 months after surgery

• The expression of CD86

  up to 3 months after surgery

• The expression of CD163

  up to 3 months after surgery

Study Arms (1)

CRT+PD-1 inhibitor+Thymalfasin

EXPERIMENTAL

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

Combination Product: SBRT with Sequential AG regimen +Tislelizumab+Thymalfasin

Interventions

SBRT with Sequential AG regimen +Tislelizumab+Thymalfasin 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.

CRT+PD-1 inhibitor+Thymalfasin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years, with ECOG score of 0 \~ 1;
• Histologically or cytologically confirmed diagnosis of ductal adenocarcinoma of pancreas;
• Classification as borderline resectable pancreatic cancer according to the NCCN Guidelines (2024 Edition);
• Deemed suitable for neoadjuvant therapy following discussion by the MDT team of the study site;
• Subjects must meet the following criteria for hematology test:
• Neutrophil count ≥ 1.5 × 10\^9/L
• Hemoglobin ≥ 10 g/dL
• Platelet count ≥ 100 × 10\^9/L
• Subjects must meet the following criteria for blood chemistry tests:
• Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
• AST and ALT \< 1.5 × ULN
• Creatinine clearance ≥ 60 mL/min
• Good coagulation, defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN
• Subjects of childbearing potential should take appropriate protective measures (contraceptive methods or other birth control methods) prior to enrollment and throughout the clinical study;
• Has signed the informed consent form;

You may not qualify if:

• Prior systemic anti-tumor therapy;
• 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);
• Prior history of abdominal radiotherapy;
• Subjects with active bacterial or fungal infection (≥ Grade 2 as per NCI-CTC, Version 3).
• 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;
• Subjects with autoimmune diseases or immunodeficiency and requiring treatment with immunosuppressive agents;
• Pregnant or lactating women; women of childbearing potential must have a negative pregnancy test results within 7 days prior to enrollment;
• Subjects with drug abuse/clinical/psychological/social factors that affect informed consent or study conduct;
• Subjects who may be allergic to PD-1 monoclonal antibody immunotherapy drugs;
• Patients who are scheduled to undergo or have previously undergone organ or bone marrow transplant;
• 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;
• Treatment with live vaccines within 28 days prior to the first dose; except for inactivated viral vaccines for seasonal influenza;
• Active pulmonary tuberculosis;
• 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.);
• Patients with other conditions unsuitable for this clinical trial judged by the investigator.

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Carcinoma, Pancreatic Ductal

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Baiyong Shen, PhD,MD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Jiabin Jin, PhD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiabin Jin, PhD

CONTACT

+86 18101870031; jjb11501@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 27, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share