Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer.
Ronan J Kelly, Jaffer A Ajani, Jaroslaw Kuzdzal...
https://pubmed.ncbi.nlm.nih.gov/33789008Actively Recruiting
Phase 2
Age: 18Years - 75Years
All Genders
ID06056336
Perioperative Immunoagent (Tislelizumab) Plus Chemotherapy for Locally Advanced Resectable Thoracic Oesophageal Squamous Cell Carcinoma Trial: A Prospective Single-arm Phase II Study
Led by Guo Xufeng · Updated on 2023-09-28
73
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with thoracic esophageal squamous cell carcinoma who receive neoadjuvant immunotherapy combined with chemotherapy followed by surgical removal of the tumor. The purpose is to assess whether adding further adjuvant therapy after surgery improves survival outcomes. This phase II study focuses on patients with specific clinical stages of esophageal cancer based on established cancer staging criteria. Eligible patients receive two cycles of neoadjuvant treatment with tislelizumab (200 mg every 3 weeks) and chemotherapy drugs nad-paclitaxel and carboplatin. After surgery with complete tumor removal (R0 resection), patients with no pathological residual cancer (pCR) receive tislelizumab for up to 30 weeks, while those without pCR receive two cycles of adjuvant immunotherapy plus chemotherapy followed by tislelizumab for 24 weeks. This approach evaluates the impact of additional therapy based on surgical response. Participants undergo regular assessments including imaging, pathological evaluation four weeks after surgery, and long-term follow-up for up to five years. Researchers monitor disease-free survival, overall survival, tumor response rates, surgical success, and adverse events. The main outcome is two-year disease-free survival among patients without complete response. Safety and effectiveness measures continue throughout the study and extended observation periods.
CONDITIONS
Brief Title
Perioperative Tislelizumab Plus Chemotherapy for Resectable Thoracic Oesophageal Squamous Cell Carcinoma
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patient volunteers and consents to participate with good compliance and willingness to follow the study protocol
- Histologically confirmed squamous cell carcinoma located in the thoracic esophagus
- No prior systemic or local treatment for esophageal cancer
- Clinical stage cT1b-3N1-3M0 or T3N0M0 based on AJCC/UICC 8th edition
- Male or female aged between 18 and 75 years
- ECOG performance status 0 or 1
- Expected to achieve complete tumor removal (R0 resection)
- Adequate cardiac function confirmed by ECG and echocardiography if needed
- Adequate respiratory function with specified lung test results
- Adequate bone marrow, liver, and renal function within defined laboratory limits
- Fertile women must have a negative pregnancy test and use effective contraception during and 3 months after treatment; men must use contraception during and 3 months after treatment
You will not qualify if you...
- Tumors that cannot be surgically removed or surgical contraindications or refusal of surgery
- Supraclavicular lymph node metastasis
- Poor nutritional status with BMI below 18.5 kg/m2 unless corrected before enrollment
- Allergy to any study drugs
- Prior radiotherapy, chemotherapy, immunosuppressive drugs, or major surgery within specified timeframes before study drug
- Active infections including HIV, hepatitis B or C
- Uncontrolled cardiac diseases or recent severe heart events
- Severe infection within 4 weeks before study drug
- Participation in other drug trials within 4 weeks before randomization
- Interstitial lung disease, pulmonary fibrosis, active pneumonia, or severe lung damage
- Active autoimmune diseases or history of such diseases requiring systemic treatment
- Prior treatment with PD-1/PD-L1 inhibitors or similar immune checkpoint therapies
- Other cancers diagnosed within 5 years except low-risk skin or cervical cancers
- Pregnant or breastfeeding women
- Other serious medical or mental conditions, substance abuse, or social factors affecting safety or adherence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Neoadjuvant Treatment
Duration - Approximately 6 weeks (2 cycles every 3 weeks)
Participants receive neoadjuvant immunotherapy with tislelizumab combined with chemotherapy before surgery.
2 visits (in-person) every 3 weeks
Surgery
Duration - 1 day (surgery day)
Participants undergo surgery for tumor removal following neoadjuvant treatment.
1 visit (in-person)
Adjuvant Treatment
Duration - Up to 30 weeks of tislelizumab treatment, plus 2 cycles of chemotherapy if non-pCR
After surgery, participants receive adjuvant immunotherapy with tislelizumab, with or without chemotherapy depending on tumor response.
Visits every 3 weeks during treatment, total duration up to 30 weeks
Follow-up Monitoring
Duration - Up to 5 years
Participants are monitored for disease-free survival and overall health after completion of adjuvant treatment.
Periodic visits for assessments up to 5 years
Trial Site Locations
Total: 1 location
1
Shanghai chest hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
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Research Team
X
Xufeng Guo, PH.D
X
Xufeng Guo, Ph.D
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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Published Research Related To This Trial
Long-term Efficacy of Neoadjuvant Chemoradiotherapy Plus Surgery for the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma: The NEOCRTEC5010 Randomized Clinical Trial.
Hong Yang, Hui Liu, Yuping Chen...
https://pubmed.ncbi.nlm.nih.gov/34160577Patterns of recurrence after surgery alone versus preoperative chemoradiotherapy and surgery in the CROSS trials.
Vera Oppedijk, Ate van der Gaast, Jan J B van Lanschot...
https://pubmed.ncbi.nlm.nih.gov/24419108