RecruitingPhase 3NCT06563869

Sintilimab With Chemotherapy Plus PEG-rhG-GSF for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma

Efficacy and Safety of Sintilimab in Combination With Platinum-containing Chemotherapy Plus PEG-rhG-GSF for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma: a Prospective, Open, Single-arm, Single-center Clinical Study


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

40 participants

Start Date

Feb 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a prospective, open-label, single-arm, single-center clinical study, aiming to evaluate the efficacy and safety of sintilimab combined with platinum-based chemotherapy + pegylated recombinant human granulocyte stimulating factor as neoadjuvant treatment for resectable esophageal squamous cell carcinoma patients. In the study, all patients who meet the inclusion criteria will receive sintilimab combined with platinum-based chemotherapy for 2 cycles (21 days as one cycle) as neoadjuvant treatment according to the study plan. Pegylated recombinant human granulocyte stimulating factor will be given 24 hours after the end of chemotherapy, and radical surgical treatment will be received within 3-6 weeks after the completion of the last neoadjuvant treatment. Whether the subjects need adjuvant treatment after surgery and the adjuvant treatment plan will be determined by the investigators. All subjects need to complete the follow-up plan formulated by the study after surgery.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding the immunotherapy drug sintilimab to standard chemotherapy (plus a white blood cell booster called PEG-rhG-CSF) before surgery can improve outcomes for patients with esophageal squamous cell carcinoma — a type of esophageal cancer — that may be surgically removable. **You may be eligible if...** - You are age 18–75 with newly diagnosed esophageal squamous cell carcinoma confirmed by biopsy - Your cancer is located in the middle or lower esophagus and is potentially operable - You have not received any prior cancer treatment (surgery, chemo, radiation, or immunotherapy) - Your general health is good (ECOG 0–1) - Your blood counts, liver, kidney, and heart function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has already spread to the neck lymph nodes or other organs - You have a history of other cancers in the past 5 years - You have active autoimmune disease or are on long-term steroid therapy - You are pregnant or breastfeeding - You have active hepatitis B or C, or HIV Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPEG-rhG-GSF

Polyethylene glycolylated recombinant human granulocyte stimulating factor (6mg)will be given 24 hours after the end of chemotherapy.


Locations(1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT06563869


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