Actively Recruiting

Phase 2
Age: 75Years +
All Genders
NCT06555471

A Single-arm, Phase II Exploratory Study of Sintilimab in Combination With Chemoradiotherapy in Elderly Patients With Locally Advanced Gastric Cancer

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-08-15

40

Participants Needed

1

Research Sites

177 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial is a prospective, single-arm, single-centre, phase II clinical study to explore the efficacy and safety of sintilimab in combination with chemoradiation in subjects over 75 years of age with advanced gastric cancer. Participants will: Take sintilimab (200mg iv q3w d1) combined with chemoradiation. The application of chemotherapy based on investigator's assessment, and if so, S-1 (po d1-d14，q3w； according to body surface area ：\<1.5m\^2 40mg/time；1.5\~1.8m\^2 50mg/time；\>1.8m2 60mg/time) or capecitabine （1000mg/m2 Bid po d1-14，q3w，Reduce or discontinue depending on the condition of the subject.); Radiotherapy：once a day, five times a week, at a dose of 1.8-2 Gy/f, for a total of 45-50.4 Gy. Radiation therapy starts from the first cycle of Sintilimab Injection combined with chemotherapy. Subjects undergo an initial assessment of imaging, physical status, quality of life, and relevant laboratory tests after completion of 3 cycles of sintilimab combination chemotherapy, followed by assessments every 2 months, and after 3 full assessments, assessments every 3 months are initiated.

CONDITIONS

Official Title

A Single-arm, Phase II Exploratory Study of Sintilimab in Combination With Chemoradiotherapy in Elderly Patients With Locally Advanced Gastric Cancer

Who Can Participate

Age: 75Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histopathologically confirmed locally advanced (T3-4N+M0) adenocarcinoma of the stomach and gastroesophageal junction, including signet ring cell, mucinous, and hepatoid types
  • HER-2 negative status
  • Age 75 years or older
  • ECOG performance status 0 to 2
  • At least one measurable or assessable lesion by RECIST v1.1
  • Adequate organ and bone marrow function, including specific blood counts, liver, kidney, coagulation, cardiac, and thyroid function thresholds
  • Expected survival time of at least 12 weeks
  • Signed informed consent and ability to comply with study visits and procedures
Not Eligible

You will not qualify if you...

  • Active bleeding from the lesion seen on endoscopy
  • Near obstruction of cardia or pylorus affecting feeding or swallowing
  • HER-2 positive adenocarcinoma diagnosis
  • Previous systemic therapy for advanced or metastatic gastric or gastroesophageal adenocarcinoma
  • Other malignant diseases diagnosed within 5 years, except certain skin cancers
  • Participation in other interventional studies or investigational treatments within 4 weeks
  • Prior therapy with anti-PD-1, anti-PD-L1, or related immune checkpoint drugs
  • Active autoimmune disease needing systemic therapy within 2 years
  • Systemic glucocorticoid or immunosuppressive therapy within 7 days before first dose (physiological doses allowed)
  • History of allogeneic organ or stem cell transplantation (except corneal)
  • Severe allergies to monoclonal antibodies or chemotherapy components
  • Unresolved toxicity from previous treatments above grade 1 except malaise or hair loss
  • Known HIV infection
  • Untreated active hepatitis B or certain hepatitis B statuses without proper monitoring
  • Active hepatitis C infection
  • Live vaccination within 30 days before first dose (except inactivated influenza vaccine)
  • Serious uncontrolled illnesses including certain heart conditions, unstable angina, recent thrombosis, uncontrolled blood pressure, recent pneumonia requiring steroids, active lung disease, tuberculosis, infections, diverticulitis, abscess, gastrointestinal obstruction, liver disease, poorly controlled diabetes, significant proteinuria, mental disorders impairing cooperation
  • Any medical condition or abnormal test that may interfere with study participation or results as judged by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Jiangsu Province Hospital

Nanjing, Jiangsu, China, 210029

Actively Recruiting

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Research Team

Y

Yan Yang

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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