Actively Recruiting

Early Phase 1
Age: 18Years - 85Years
All Genders
NCT06329908

DC Combined With ICIs in the Treatment of Advanced Lung Cancer Resistant to ICIs

Led by Zhen-Yu Ding · Updated on 2024-03-26

20

Participants Needed

1

Research Sites

161 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a single-center, single-arm, prospective clinical trial to investigate the safety and efficacy of Neo-DCVac combined with ICIs in the treatment of advanced lung cancer resistant to ICIs.

CONDITIONS

Official Title

DC Combined With ICIs in the Treatment of Advanced Lung Cancer Resistant to ICIs

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-85 years.
  • ECOG performance status score of 0 to 2.
  • Confirmed diagnosis of non-small cell lung cancer, stage IIIB-IV according to AJCC version 8.
  • Previously treated with first-line chemotherapy combined with immune checkpoint inhibitors (PD1/PD-L1) and developed drug resistance.
  • Normal major organ function as shown by: a) blood counts (granulocyte count 63 1.5 x 10^9/L, platelet count 63 80 x 10^9/L, hemoglobin 63 80 g/L) without recent use of growth factors or transfusions; b) liver function (total bilirubin 64 1.5 times upper limit of normal, ALT or AST 64 2.5 times upper limit of normal); c) kidney function (creatinine clearance 63 60 mL/min); d) coagulation (INR or PT 64 1.5 times upper limit of normal or within drug-specific range if using anticoagulants); e) urine protein within acceptable limits.
  • Female participants of childbearing potential and male participants with partners of childbearing potential agree to use effective contraception during and for 6 months after treatment.
  • Willingness to voluntarily participate and sign informed consent.
Not Eligible

You will not qualify if you...

  • Mixed pathological types including small cell carcinoma or other components.
  • Presence of blood-borne infectious diseases such as HIV.
  • History of mental disorders or drug abuse.
  • Any other cancer except completely cured cervical carcinoma in situ or basal/squamous cell skin cancer within the past 3 years.
  • Autoimmune diseases or long-term use of immunosuppressive drugs or steroids.
  • Unstable systemic diseases including serious gastrointestinal, cardiovascular, metabolic, or infectious conditions.
  • Active central nervous system metastases; previously treated brain metastases allowed if stable and off corticosteroids.
  • Anti-tumor therapy including chemotherapy, radiotherapy, or targeted therapy within 3 weeks before study drug.
  • Symptomatic pleural, pericardial effusions, or ascites requiring drainage.
  • Use of anti-tumor or live vaccines within 30 days prior.
  • Difficulty communicating or following up long-term.
  • Pregnant or breastfeeding women.
  • Participation in other clinical trials currently or planned.
  • Other situations deemed unsuitable by the investigator.

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

West China Hospital

Chengdu, Sichuan, China, 610000

Actively Recruiting

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Research Team

Z

Zhengyu Ding, MD

CONTACT

Q

Qing Li, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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