Actively Recruiting
Sintilimab With Chemotherapy Plus PEG-rhG-GSF for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-08-21
40
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sintilimab With Chemotherapy Plus PEG-rhG-GSF for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent voluntarily
- Male or female aged 18 to 75 years
- Diagnosed with esophageal squamous cell carcinoma by biopsy, with cervical metastasis excluded
- Tumor located in the middle or lower esophagus below 18 cm from incisors, assessed as potentially resectable (T2-4aNxM0, stage II-IVA)
- For T2N0M0 tumors, primary tumor length ≥ 2 cm, located below the neck and ≥ 5 cm from cricopharyngeal muscle
- No prior anti-tumor treatment (surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.)
- ECOG performance status 0-1
- Adequate heart, lung, liver and kidney functions with laboratory tests meeting specified thresholds within 14 days before screening
- Able to complete treatment and follow-up as planned
- Sufficient tissue samples available and consent to use tissue and blood samples for research
- Negative pregnancy test for women of childbearing age and willing to use effective contraception during the study
You will not qualify if you...
- Risk of tracheoesophageal or aortic esophageal fistula
- Severe malnutrition or requiring tube feeding
- Other malignant tumors within 2 years not cured (except cured basal cell skin carcinoma and cervical carcinoma in situ)
- Active or history of autoimmune diseases requiring systemic hormone or anti-autoimmune therapy
- Immunodeficiency or receiving systemic steroid therapy (>10 mg prednisone daily) or other immunosuppressants within 7 days before treatment
- Active infection requiring systemic treatment within 7 days before treatment
- Uncontrolled systemic diabetes
- Interstitial lung disease, non-infectious pneumonia, or pulmonary fibrosis
- Previous motor or sensory nerve toxicity greater than WHO grade 1
- Past allogeneic organ or stem cell transplantation
- Allergy to study drugs or related components
- Participation in other clinical studies
- Received PD-1/PD-L1 or CTLA-4 immune or targeted therapies within 4 weeks before screening
- Serious or unstable medical or mental illness
- Known active alcohol or drug abuse or dependence
AI-Screening
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Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
Y
Yanhong Gu, Ph.D.
CONTACT
T
Ting Wang, Ph.D.
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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