Pancreatic CancerPhase 2NCT06359275
PD-1 Combined With Chemotherapy and PULSAR in LAPC and Local Recurrence Patients
A Phase 2 study testing PD-1, Nab-paclitaxel and Gemcitabine in people with Pancreatic Cancer, run by Fudan University at 1 site in China.
Trial summary
This trial is a phase II clinical trial of the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR radiotherapy in patients with locally advanced unresectable pancreatic cancer and patients with only local recurrence after pancreatic cancer… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- PD-1, Nab-paclitaxel and Gemcitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to Oct 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
- Sign the informed consent form. The subject has received a full explanation and understanding of the purpose, content, predicted efficacy, pharmacological effects, and risks of this trial, and the subject has signed an informed consent form;
- Target group
- Locally advanced pancreatic adenocarcinoma confirmed by histopathology or cytology, or pancreatic cancer with only local recurrence but no distant metastasis after surgery (local recurrence includes tumor bed recurrence and regional lymph node metastasis, which needs to be confirmed by biopsy pathology or PET -CT shows high metabolic activity, more than 6 months after the completion of postoperative adjuvant treatment);
- There is at least one measurable objective lesion according to RECIST1.1 standards;
- ECOG score 0-1 points;
- Expected survival time ≥ 3 months;
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- Willing to comply with research procedures and able to undergo treatment (including surgery) and follow-up;
- There are no contraindications for the use of PD-1, PD-L1, gemcitabine and paclitaxel for injection (albumin-bound);
- There are no contraindications to radiotherapy;
- Abnormal physical examination and laboratory test results
- Hematological dysfunction is defined as i) absolute neutrophil (ANC) count ≥1.5×109/L; ii) platelet (PLT) count: ≥80×109/L; iii) hemoglobin (Hb) level ≥ 90g/L.
- Abnormal liver function is defined as: i) Total bilirubin (TBil) level: ≤ 1.5 times the upper limit of normal (ULN); ii) Aspartate aminotransferase (AST) and alanine; aminotransferase (ALT) levels ≤ 2.5 times the ULN, if liver metastasis is present, ≤5 times ULN;
- Abnormal renal function definition: serum creatinine ≤ 1.5 times ULN, or calculated creatinine clearance ≥ 50ml/min;
- Definition of abnormal coagulation function: international normalized ratio (INR) ≤ 1.5 times ULN, and prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN, unless the subject is receiving anti- Coagulation treatment.
- Subjects who are positive for hepatitis B surface antigen (HBsAg) and whose peripheral blood hepatitis B virus deoxyribonucleic acid (HBV-DNA) titer is ≤1×103 copy number/L; if they are HBsAg-positive and whose peripheral blood HBV-DNA titer is detected ≥1×103 copy number/L, if the researcher believes that the subject's chronic hepatitis B is in a stable phase and will not increase the subject's risk, the subject is eligible for inclusion;
- Age and reproductive status
- Men and women aged 18-75;
- Subjects of childbearing age must agree to take adequate contraceptive measures during the trial; the serum or urine pregnancy test of women of childbearing age must be negative 24 hours before the start of chemotherapy;
- Women must be non-lactating.
Who cannot join
- Have received anti-PD-1 or anti-PD-L1 antibody treatment in the past;
- Have received any investigational drugs within 4 weeks before using the investigational drugs for the first time;
- Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up;
- Have received radiotherapy for the upper abdomen in the past;
- Medical history and concurrent diseases
- Uncontrolled serious medical diseases that the researcher believes will affect the subject's ability to receive the treatment of the research plan, such as combined with serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, and uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc;
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- Have active, known, or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and need for bronchodilators treatment of asthma, etc.). Subjects with hypothyroidism requiring only hormone replacement therapy and skin diseases not requiring systemic treatment (such as vitiligo, psoriasis, or alopecia) were eligible;
- Have active tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year before the medication will be excluded, even if they have been treated; patients with a history of active pulmonary tuberculosis infection more than one year ago will also be excluded unless it is proven that they have previously received standard anti-tuberculosis treatment;
- Previous interstitial lung disease or (non-infectious) pneumonia requiring oral or intravenous steroid therapy;
- Long-term systemic corticosteroids (dose equivalent to >10 mg prednisone/day) or any other form of immunosuppressive treatment are required. Subjects using inhaled or topical corticosteroids were eligible;
- Heart disease that is not well controlled, such as:
- New York Heart Association (NYHA) grade 2 or above heart failure
- Unstable angina pectoris
- Myocardial infarction occurred within 1 year
- Supraventricular or ventricular arrhythmias that are clinically significant and require treatment or intervention;
- Dementia, altered mental status, or any mental illness that would prevent understanding or giving informed consent or completing questionnaires;
- History of allergy or hypersensitivity reaction to any component of the treatment;
- Malignant tumors within 5 years, except for fully treated basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery;
- Previous systemic treatment for locally advanced pancreatic cancer;
- Subjects who have been pathologically diagnosed with squamous cell carcinoma (not limited to organs) and received taxane-containing regimens as neoadjuvant/adjuvant treatment;
- Subjects with ≥ grade 2 peripheral neuropathy according to CTCAE version 5.0.
- Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) antibody positive;
- Active infection requiring systemic treatment;
- Need to be combined with other anti-tumor drug treatments;
- Have received any experimental drug treatment or participated in another interventional clinical trial within 30 days of the screening period;
- The researcher believes that other circumstances are not suitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanhai
Weijing Zhang, 021-64175590, andwater@163.com
About this study
Official title: A Phase II Study on the Safety and Efficacy of PD-1 Combined With Nab-paclitaxel/Gemcitabine and PULSAR in the Treatment of Locally Advanced Unresectable Pancreatic Cancer and Local Recurrence After Surgery.
This trial is a phase II clinical trial of the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR radiotherapy in patients with locally advanced unresectable pancreatic cancer and patients with only local recurrence after pancreatic cancer surgery, to observe the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR in the treatment of patients with locally advanced unresectable pancreatic cancer.
Read the detailed description
This trial is a phase II clinical trial of the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR radiotherapy in patients with locally advanced unresectable pancreatic cancer and patients with only local recurrence after pancreatic cancer surgery, to observe the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR in the treatment of patients with locally advanced unresectable pancreatic cancer.
Progression-free survival (PFS), objective response rate (ORR), overall survival (OS), surgical conversion rate, and quality of life were observed in subjects with locally advanced unresectable pancreatic cancer with precise histological or cytological diagnosis and patients with only local recurrence after surgery. This is a single-center study. A total of 46 subjects with locally advanced unresectable pancreatic cancer and 35 subjects with locally recurrent pancreatic cancer after surgery were planned to be enrolled.
The estimated enrollment time is 18 months, with at least 18 months of follow-up for each subject.
This trial will evaluate the safety data of all subjects who have received at least one dose of study treatment for analysis. The National Cancer Institute (NCI) Common Adverse Event Evaluation Criteria (CTCAE version 5.0) were used. The efficacy evaluation was done according to the clinical diagnosis and treatment routine-follow-up patients combined with follow-up records.
- Conditions
- Pancreatic Cancer
- Being tested
- PD-1, Nab-paclitaxel, Gemcitabine, PULSAR
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1Drug
Also called immunotherapy
Toripalimab，240 mg/time，D1， Q3W
Nab-paclitaxelDrug
Also called chemotherapy
Nab-paclitaxel, 125mg/m2，IV，D1，8, Q3W
GemcitabineDrug
Also called chemotherapy
Gemcitabine，1000mg/m2，IV，D1，8，Q3W
PULSARRadiation
Also called radiotherapy
5-10 Gy per session, a total of 5 times.
| Study group | Role | What they receive |
|---|---|---|
| PD-1 Combined With chemotherapy + PULSAR. | Experimental | Toripalimab: 240 mg/time, intravenously infused over 30 minutes， administered once every three weeks until the treatment termination event specified in the protocol occurs.
Paclitaxel for injection (albumin-bound): 125 mg/m2 and infuse intravenously for at least 30 minutes: D1, 8 days of administration. Every 21 days is a cycle.
Gemcitabine hydrochloride for injection: 1000 mg/m2 for intravenous infusion over 30 minutes: D1, 8 days of administration. Every 21 days is a cycle.
PULSAR: Hypofractionated or stereotactic radiotherapy for the primary pancreatic tumor lesions and surrounding metastatic lymph nodes, 5-10 Gy/time, in conjunction with the chemotherapy cycle, completed once within each chemotherapy cycle, for a total of 5 times. Receives: Drug: PD-1; Drug: Nab-paclitaxel; Drug: Gemcitabine; Radiation: PULSAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS is defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first.
Measured: up to approximately 1 years
Secondary outcomes (3)
Objective response rate (ORR)
ORR is defined as the percentage of subjects with complete response (CR) or partial response (PR) by investigator assessment per RECIST criteria, version 1.1.
Measured: up to approximately 1 years
Overall survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
Measured: up to approximately 1 years
Surgical Conversion Rate
The surgery is scheduled to take place after a minimum of 4 weeks from the last dose to allow the effects of the drug to wear off. The eligible subjects can undergo surgery within 8 weeks from the last dose. A successful resection is achieved when a patient achieves R0 or R1 resection. However, if a patient has R2 resection or unresectable, then it is considered as resection failure. The pathology committee of our center determines the surgical results of R0, R1, and R2 based on the tissue obtained during the operation.
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start1 Jun 2024
- Primary completionDec 2025 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xian-Jun Yu, Fudan University
- Investigators
- Weijing Zhang, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359275
- Sponsor's protocol ID
- iPULSAR-PC
- Status last verified
- Jun 2024
- First submitted
- 6 Apr 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study on the Safety and Efficacy of PD-1 Combined With Nab-paclitaxel/Gemcitabine and PULSAR in the Treatment of Locally Advanced Unresectable Pancreatic Cancer and Local Recurrence After Surgery.
- ClinicalTrials.gov ID
- NCT06359275
- Acronym / sponsor ID
- iPULSAR-PC
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 11 Apr 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 trial is a phase II clinical trial of the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR radiotherapy in patients with locally advanced unresectable pancreatic cancer and patients with only local recurrence after pancreatic cancer surgery, to observe the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR in the treatment of patients with locally advanced unresectable pancreatic cancer.
Detailed description
This trial is a phase II clinical trial of the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR radiotherapy in patients with locally advanced unresectable pancreatic cancer and patients with only local recurrence after pancreatic cancer surgery, to observe the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR in the treatment of patients with locally advanced unresectable pancreatic cancer.
Progression-free survival (PFS), objective response rate (ORR), overall survival (OS), surgical conversion rate, and quality of life were observed in subjects with locally advanced unresectable pancreatic cancer with precise histological or cytological diagnosis and patients with only local recurrence after surgery. This is a single-center study. A total of 46 subjects with locally advanced unresectable pancreatic cancer and 35 subjects with locally recurrent pancreatic cancer after surgery were planned to be enrolled.
The estimated enrollment time is 18 months, with at least 18 months of follow-up for each subject.
This trial will evaluate the safety data of all subjects who have received at least one dose of study treatment for analysis. The National Cancer Institute (NCI) Common Adverse Event Evaluation Criteria (CTCAE version 5.0) were used. The efficacy evaluation was done according to the clinical diagnosis and treatment routine-follow-up patients combined with follow-up records.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-1 Combined With chemotherapy + PULSAR. | Experimental | Drug: PD-1, Drug: Nab-paclitaxel, Drug: Gemcitabine, Radiation: PULSARToripalimab: 240 mg/time, intravenously infused over 30 minutes， administered once every three weeks until the treatment termination event specified in the protocol occurs. Paclitaxel for injection (albumin-bound): 125 mg/m2 and infuse intravenously for at least 30 minutes: D1, 8 days of administration. Every 21 days is a cycle. Gemcitabine hydrochloride for injection: 1000 mg/m2 for intravenous infusion over 30 minutes: D1, 8 days of administration. Every 21 days is a cycle. PULSAR: Hypofractionated or stereotactic radiotherapy for the primary pancreatic tumor lesions and surrounding metastatic lymph nodes, 5-10 Gy/time, in conjunction with the chemotherapy cycle, completed once within each chemotherapy cycle, for a total of 5 times. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Sign the informed consent form. The subject has received a full explanation and understanding of the purpose, content, predicted efficacy, pharmacological effects, and risks of this trial, and the subject has signed an informed consent form;
- Target group
- Abnormal physical examination and laboratory test results
- Subjects who are positive for hepatitis B surface antigen (HBsAg) and whose peripheral blood hepatitis B virus deoxyribonucleic acid (HBV-DNA) titer is ≤1×103 copy number/L; if they are HBsAg-positive and whose peripheral blood HBV-DNA titer is detected ≥1×103 copy number/L, if the researcher believes that the subject's chronic hepatitis B is in a stable phase and will not increase the subject's risk, the subject is eligible for inclusion;
- Age and reproductive status
Key exclusion criteria (26 listed)
- Have received anti-PD-1 or anti-PD-L1 antibody treatment in the past;
- Have received any investigational drugs within 4 weeks before using the investigational drugs for the first time;
- Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up;
- Have received radiotherapy for the upper abdomen in the past;
- Medical history and concurrent diseases
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 |
|---|---|---|
| PD-1Also: immunotherapyToripalimab，240 mg/time，D1， Q3W | Drug | PD-1 Combined With chemotherapy + PULSAR. |
| Nab-paclitaxelAlso: chemotherapyNab-paclitaxel, 125mg/m2，IV，D1，8, Q3W | Drug | PD-1 Combined With chemotherapy + PULSAR. |
| GemcitabineAlso: chemotherapyGemcitabine，1000mg/m2，IV，D1，8，Q3W | Drug | PD-1 Combined With chemotherapy + PULSAR. |
| PULSARAlso: radiotherapy5-10 Gy per session, a total of 5 times. | Radiation | PD-1 Combined With chemotherapy + PULSAR. |
Primary outcome
Progression-free survival (PFS)
Time frame: up to approximately 1 years
PFS is defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first.
3 secondary outcomes
Objective response rate (ORR)
Time frame: up to approximately 1 years
Overall survival (OS)
Time frame: up to approximately 1 years
Surgical Conversion Rate
Time frame: 18 weeks
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 25 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Weijing Zhang study chair
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD-1, Nab-paclitaxel and Gemcitabine in people with Pancreatic Cancer, run by Fudan University at 1 site in China.
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 19 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Si Shi, PHD (+86-021-64179375, shisi@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: up to approximately 1 years). 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 25 Jun 2024.