PD-1 Combined With Chemotherapy and PULSAR in LAPC and Local Recurrence Patients

NCT06359275 | Recruiting Phase 2

• 1 other identifier: iPULSAR-PC
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  up to approximately 1 years

Secondary Outcomes (3)

• Objective response rate (ORR)

  up to approximately 1 years

• Overall survival (OS)

  up to approximately 1 years

• Surgical Conversion Rate

  18 weeks

Study Arms (1)

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.

Drug: PD-1; Drug: Nab-paclitaxel; Drug: Gemcitabine; Radiation: PULSAR

Interventions

PD-1 DRUG

Toripalimab，240 mg/time，D1， Q3W

Also known as: immunotherapy

PD-1 Combined With chemotherapy + PULSAR.

Nab-paclitaxel DRUG

Nab-paclitaxel, 125mg/m2，IV，D1，8, Q3W

Also known as: chemotherapy

PD-1 Combined With chemotherapy + PULSAR.

Gemcitabine DRUG

Gemcitabine，1000mg/m2，IV，D1，8，Q3W

Also known as: chemotherapy

PD-1 Combined With chemotherapy + PULSAR.

PULSAR RADIATION

5-10 Gy per session, a total of 5 times.

Also known as: radiotherapy

PD-1 Combined With chemotherapy + PULSAR.

Eligibility Criteria

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

You may qualify if:

• 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;
• 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.
• Age and reproductive status

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanhai, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Immunotherapy; 130-nm albumin-bound paclitaxel; Drug Therapy; Gemcitabine; DEAE-Dextran; Radiotherapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Dextrans; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Weijing Zhang

  Fudan University

  STUDY CHAIR

Central Study Contacts

Si Shi, PHD

CONTACT

+86-021-64179375; shisi@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 11, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)