Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06475417

Neoadjuvant Adebrelimab + DOS in Locally Advanced Resectable Gastric Cancer

Led by Tang-Du Hospital · Updated on 2024-06-26

42

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

Sponsors

T

Tang-Du Hospital

Lead Sponsor

J

Jiangsu Hengrui Pharmaceutical Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

To evaluate the efficacy and safety of adebrelimab combined DOS in neoadjuvant treatment of locally advanced resectable gastric cancer.

CONDITIONS

Official Title

Neoadjuvant Adebrelimab + DOS in Locally Advanced Resectable Gastric Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants voluntarily agree and provide informed consent.
  • Age between 18 and 75 years, any gender.
  • Histopathological confirmation of locally advanced gastric or gastroesophageal junction adenocarcinoma by biopsy.
  • Clinical staging of T2-3N+M0 or T4aNanyM0 confirmed by imaging and endoscopic ultrasound.
  • ECOG performance status of 0 or 1.
  • Expected survival of at least 12 weeks.
  • Adequate blood counts: Hemoglobin ≥ 90 g/L, ANC ≥ 1.5 × 10^9/L, Platelets ≥ 80 × 10^9/L with no recent transfusions.
  • Liver and kidney function within limits: Total bilirubin ≤ 1.5 × ULN, ALT and AST ≤ 2.5 × ULN, Creatinine ≤ 1.5 × ULN or clearance ≥ 60 ml/min.
  • Left ventricular ejection fraction ≥ 50%.
  • Female participants of childbearing potential must have negative pregnancy tests and agree to use contraception during and 6 months after the study; male participants must also agree to contraception use.
  • Willingness to comply with study protocol and follow-up visits.
Not Eligible

You will not qualify if you...

  • History of other malignancies within 5 years, except cured cervical carcinoma in situ, non-melanoma skin cancer, or superficial bladder tumors.
  • Tumors invading adjacent organs with high bleeding or fistula risk.
  • Use of systemic corticosteroids (>10 mg prednisone daily) or immunosuppressants within 14 days before treatment, except controlled inhaled or topical corticosteroids.
  • Severe malnutrition requiring intravenous nutrition or continuous infusion.
  • Receipt of live or attenuated vaccines within 30 days after first treatment.
  • Unresolved severe toxicities (grade ≥4) from previous treatments, except alopecia and mild neuropathy.
  • Allergies or contraindications to study drugs.
  • Severe or uncontrolled diseases including heart, lung, kidney, infectious, immune, or metabolic disorders.
  • Current gastrointestinal diseases posing bleeding, obstruction, or perforation risk.
  • Recent surgery, biopsy, or major injury within 28 days before enrollment.
  • Recent significant bleeding events or unhealed wounds.
  • Recent thrombotic events within 3 months.
  • Planned or previous allogeneic organ or bone marrow transplantation.

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

Tangdu Hospital Affiliated to the Fourth Military Medical University

Xi'an, Shannxi, China, 710038

Actively Recruiting

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Research Team

N

Nan Wang, Dr

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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