Actively Recruiting
Camrelizumab Plus Neoadjuvant Chemotherapy or Chemoradiotherapy Versus Chemoradiotherapy in Resectable ESCC.
Led by Zhigang Li · Updated on 2024-10-17
426
Participants Needed
5
Research Sites
486 weeks
Total Duration
On this page
Sponsors
Z
Zhigang Li
Lead Sponsor
J
Jiangsu HengRui Medicine Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to explore the effectiveness and safety of neoadjuvant immune combined chemotherapy or radiochemotherapy compared with traditional neoadjuvant radiochemotherapy in patients with locally advanced Esophageal Squamous Cell Carcinoma.
CONDITIONS
Official Title
Camrelizumab Plus Neoadjuvant Chemotherapy or Chemoradiotherapy Versus Chemoradiotherapy in Resectable ESCC.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathological biopsy confirming esophageal squamous cell carcinoma
- No prior systemic or local treatment for esophageal cancer
- Age between 18 and 75 years inclusive
- ECOG performance status score of 0 or 1
- Thoracic esophageal cancer assessed as resectable with clinical stage T1b-3N1-3M0 or T3N0M0 (8th edition AJCC staging)
- Expected to achieve complete tumor removal (R0 resection)
- Voluntary informed consent signed before treatment
- Plan to undergo surgery after completing neoadjuvant treatment
- No contraindications for surgery
- Normal major organ function
- Female participants of childbearing potential must have a negative pregnancy test within 72 hours before starting study drug and use effective contraception during the trial and for at least 3 months after last dose; male participants with female partners of childbearing age must also use effective contraception during the trial and for 3 months after last dose
- Good compliance and ability to follow up for efficacy and adverse event monitoring
You will not qualify if you...
- Presence of unresectable tumors or contraindications for surgery, or refusal of surgery
- Supraclavicular lymph node metastasis
- Poor nutritional status with BMI less than 18.5 Kg/m2 unless corrected before randomization
- History of allergies to components of the study drugs
- Prior treatments including radiotherapy, chemotherapy, anti-tumor drugs, immunosuppressants, systemic hormones (above prednisone 10 mg/day) within specified time frames
- Live attenuated vaccine received within 4 weeks before first study drug use
- Major surgery or severe trauma within 4 weeks before first study drug use
- History of immunodeficiency including positive HIV test or organ/bone marrow transplantation
- Uncontrolled heart diseases
- Severe infections within 4 weeks before first study drug use
- Participation in other drug clinical trials within 4 weeks before randomization
- Active or history of interstitial lung diseases or severe lung dysfunction
- Active autoimmune diseases or history of autoimmune diseases with recurrence risk
- Active hepatitis B or C infection
- Other malignancies within 5 years except low-risk treated skin or cervical cancers
- Pregnant or breastfeeding women
- Other serious diseases, mental illness, substance abuse, or social factors that may affect safety or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
2
Anyang Tumour Hospital
Anyang, China
Actively Recruiting
3
Sun yat-sen University Cancer Center
Guangzhou, China
Actively Recruiting
4
Anhui Provincial Hospital
Hefei, China
Actively Recruiting
5
Zhongshan Hospital of Fudan University
Shanghai, China
Actively Recruiting
Research Team
Y
Yang Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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