Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06359275

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

Led by Fudan University · Updated on 2024-06-25

81

Participants Needed

1

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent after understanding the study purpose and risks
  • Diagnosis of locally advanced pancreatic adenocarcinoma or local recurrence after surgery confirmed by pathology or PET-CT
  • At least one measurable lesion by RECIST1.1 standards
  • ECOG performance status of 0 or 1
  • Expected survival of at least 3 months
  • Willing and able to comply with study procedures, treatment, and follow-up
  • No contraindications to PD-1/PD-L1 antibodies, gemcitabine, paclitaxel, or radiotherapy
  • Adequate blood counts: neutrophils 91.5 x 10^9/L, platelets 80 x 10^9/L, hemoglobin 90 g/L
  • Liver function within specified limits: total bilirubin 91.5x ULN, AST and ALT 92.5x ULN (or 95x ULN if liver metastases)
  • Renal function within specified limits: serum creatinine 91.5x ULN or creatinine clearance 50 ml/min
  • Coagulation parameters within limits unless on anticoagulation therapy
  • Hepatitis B surface antigen positive patients must have HBV-DNA 91 x 10^3 copies/L or stable chronic hepatitis B
  • Men and women aged 18-75
  • Women of childbearing potential must use contraception and have a negative pregnancy test
  • Women must not be breastfeeding
Not Eligible

You will not qualify if you...

  • Previous treatment with anti-PD-1 or anti-PD-L1 antibodies
  • Use of investigational drugs within 4 weeks before starting study treatment
  • Concurrent enrollment in another interventional clinical trial (except observational studies or follow-up of interventional studies)
  • Prior upper abdominal radiotherapy
  • Uncontrolled serious medical conditions such as severe heart disease, cerebrovascular disease, uncontrolled diabetes or hypertension, active infections, or peptic ulcers
  • Active or suspected autoimmune diseases requiring systemic treatment (exceptions apply for certain thyroid or skin conditions)
  • Active pulmonary tuberculosis infection within 1 year or untreated past infections
  • History of interstitial lung disease or pneumonia requiring steroid treatment
  • Need for long-term systemic corticosteroids or other immunosuppressants (inhaled/topical steroids allowed)
  • Uncontrolled heart disease including NYHA grade 2+ heart failure, unstable angina, recent myocardial infarction, or significant arrhythmias
  • Dementia or mental illness preventing informed consent or questionnaire completion
  • Allergy or hypersensitivity to study treatments
  • Other cancers within 5 years except certain treated skin, prostate, or breast cancers
  • Prior systemic treatment for locally advanced pancreatic cancer
  • Prior taxane-containing neoadjuvant/adjuvant therapy for squamous cell carcinoma
  • Peripheral neuropathy grade 2 or higher
  • Positive for hepatitis C or HIV antibodies
  • Active infections requiring systemic treatment
  • Concurrent anti-tumor drug treatments
  • Experimental drug use or interventional trial participation within 30 days
  • Any condition the investigator deems unsuitable for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanhai, China

Actively Recruiting

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Research Team

S

Si Shi, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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