Carcinoma, Pancreatic DuctalPhase 2NCT06573398
Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for BRPC
A Phase 2 study testing SBRT with Sequential AG regimen +Tislelizumab+Thymalfasin in people with Carcinoma, Pancreatic Ductal, run by Ruijin Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Pancreatic Ductal
- What is being tested?
- SBRT with Sequential AG regimen +Tislelizumab+Thymalfasin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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;
- Capable of complying with the study protocol and follow-up procedures.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for Borderline Resectable Pancreatic Cancer
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.
Read the 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
- Being tested
- SBRT with Sequential AG regimen +Tislelizumab+Thymalfasin
- Keywords
- borderline resectable, thymalfasin, radiotherapy, chemotherapy, PD-1 inhibitor, pancreatic ductal adenocarcinoma
- Medical subject headings
- Carcinoma, Pancreatic Ductal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT with Sequential AG regimen +Tislelizumab+ThymalfasinCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: SBRT with Sequential AG regimen +Tislelizumab+Thymalfasin |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
Defined as the proportion of patients in the ITT population who undergo R0 resection following neoadjuvant therapy among patients undergoing surgery.
Measured: within 10 days after surgery
Secondary outcomes (10)
Tumor regression grade (TRG)
Tumor regression grade was determined according to the postoperative pathological results.
Measured: within 10 days after surgery
Pathologic complete response (pCR) rate
Defined as the proportion of patients in the ITT population who reach pT0N0M0 among patients undergoing surgery.
Measured: within 10 days after surgery
Median progression-free survival (mPFS)
The median time from the first dose to any documented tumor progression or death due to any cause (whichever occurs first) in the ITT population. Patients who are alive at the time of analysis and have no documented disease progression will be reviewed on the date of the last imaging assessment.
Measured: 24 months
Median overall survival (mOS)
The median time from the first dose to death due to any cause in the ITT population. Patients who are alive at the time of analysis will be reviewed on their last contact date.
Measured: 24 months
Major pathologic response (MPR) rate
Defined as the proportion of patients in the ITT population who achieve TRG1 among patients undergoing surgery.
Measured: within 10 days after surgery
Objective response rate (ORR)
Defined as the proportion of patients in the ITT population achieving complete response (CR) + partial response (PR) according to iRECIST.
Measured: Baseline (before surgery)
Disease control rate (DCR)
Defined as the proportion of subjects in the ITT population who achieve disease response and stable disease among all subjects.
Measured: Baseline (before surgery)
TRAE
Incidence of treatment-related adverse event
Measured: from commencing of treatment to the 30th day after surgery
irAE
Incidence of immune-related adverse event
Measured: from commencing of PD-1 inhibitor to the 30th day after surgery
Incidence of surgical complications
Incidence of surgical complications within 30 days after surgery
Measured: within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Pancreatic DuctalStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JIABIN JIN, Ruijin Hospital
- Investigators
- Baiyong Shen, PhD,MD, Principal investigator, Ruijin HospitalJiabin Jin, PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573398
- Sponsor's protocol ID
- ZDX+PD-1+CRT-PDAC
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Export of individual patient data is a sensitive issue according to current Chinese laws.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for Borderline Resectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06573398
- Acronym / sponsor ID
- ZDX+PD-1+CRT-PDAC
- Conditions
- Carcinoma, Pancreatic Ductal
- Keywords
- borderline resectable, thymalfasin, radiotherapy, chemotherapy, PD-1 inhibitor, pancreatic ductal adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT+PD-1 inhibitor+Thymalfasin | Experimental | Combination Product: SBRT with Sequential AG regimen +Tislelizumab+ThymalfasinAll eligible 20 subjects will receive a neoadjuvant therapy regimen of chemoradiotherapy combined with anti-PD-1 monoclonal antibody and Thymalfasin. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRT with Sequential AG regimen +Tislelizumab+ThymalfasinStereotactic 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. | Combination product | CRT+PD-1 inhibitor+Thymalfasin |
Primary outcome
R0 resection rate
Time frame: within 10 days after surgery
Defined as the proportion of patients in the ITT population who undergo R0 resection following neoadjuvant therapy among patients undergoing surgery.
10 secondary outcomes
Tumor regression grade (TRG)
Time frame: within 10 days after surgery
Pathologic complete response (pCR) rate
Time frame: within 10 days after surgery
Median progression-free survival (mPFS)
Time frame: 24 months
Median overall survival (mOS)
Time frame: 24 months
Major pathologic response (MPR) rate
Time frame: within 10 days after surgery
Objective response rate (ORR)
Time frame: Baseline (before surgery)
Disease control rate (DCR)
Time frame: Baseline (before surgery)
TRAE
Time frame: from commencing of treatment to the 30th day after surgery
irAE
Time frame: from commencing of PD-1 inhibitor to the 30th day after surgery
Incidence of surgical complications
Time frame: within 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: No. Export of individual patient data is a sensitive issue according to current Chinese laws.
Related trials for Carcinoma, Pancreatic Ductal
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
RecruitingPhase 2
A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC), G12D Mutated KRAS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Baiyong Shen, PhD,MD principal investigator
Ruijin Hospital
Jiabin Jin, PhD principal investigator
Ruijin Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SBRT with Sequential AG regimen +Tislelizumab+Thymalfasin in people with Carcinoma, Pancreatic Ductal, run by Ruijin Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiabin Jin, PhD (+86 18101870031, jjb11501@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: within 10 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.