A Perioperative Sintilimab and Chemotherapy in Esophageal Squamous Cell Carcinoma
Study Details
Study Description
Brief Summary
This study is aimed to evaluate the efficacy and safety of sintilimab combined with chemotherapy versus chemotherapy in perioperative treatment of locally advanced esophageal squamous cell carcinoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
This study was designed as an open-label, randomized controlled, phase II trial. Subjects will be systematically randomized at a ratio of 1:1 and will be assigned to either the experimental group (sintilimab combined with chemotherapy group) or the control group (chemotherapy alone group). They will receive 2-3 cycles of neoadjuvant therapy followed by radical esophagectomy and lymph node dissection and adjuvant therapy determined by investigators. The primary endpoint is 1-year Event-free survival (EFS) rate.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sintilimab plus chemotherapy Sintilimab: 200mg; cisplatin: 75mg/m2, d1, routine hydration for 3 days; nab-paclitaxel: 260mg/m2, d1, every 3 weeks, 2-3 cycles. |
Drug: Sintilimab
Sintilimab (200mg) will be given intravenously on day 1 in 3-week cycles for 2-3 cycles.
Drug: Chemotherapy
Cisplatin (75mg/m2) wih routine hydration for 3 days and nab-paclitaxel (260mg/m2) will be given intravenously on day 1 in 3-week cycles for 2-3 cycles.
|
| Active Comparator: Chemotherapy Cisplatin: 75mg/m2, d1, routine hydration for 3 days; nab-paclitaxel: 260mg/m2, d1, every 3 weeks, 2-3 cycles. |
Drug: Chemotherapy
Cisplatin (75mg/m2) wih routine hydration for 3 days and nab-paclitaxel (260mg/m2) will be given intravenously on day 1 in 3-week cycles for 2-3 cycles.
|
Outcome Measures
Primary Outcome Measures
- Event-free survival (EFS) [12 months]
EFS is defined as the time from R0 resection to disease recurrence or metastases or death for subjects achieving radical resection or the time from enrollment to disease progression or death for subjects not achieving radical resection.
Secondary Outcome Measures
- R0 surgery rate [20 months]
R0 resection is defined as no cancer cells are seen microscopically at the resection margin following surgery.
- pCR rate [20 months]
Pathological Complete Response (pCR) is defined as no viable cancer cells in the hematoxylin and eosin (H&E)-stained slides from the resected tumor and lymph nodes following neoadjuvant treatment.
- Disease-free survival (DFS) [24 months]
DFS is calculated from R0 surgery to the date of recurrence or metastases or death in subjects with radical resection.
- Overall Survival (OS) [24 months]
OS is calculated from the randomization to the date of death from any cause.
- adverse events [24 months]
The incidence of treatment-related adverse events (TRAEs), severe adverse events (SAE), based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Eligibility Criteria
Criteria
Inclusion Criteria:
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Esophageal squamous cell carcinoma suggested by gastroscopic histopathology.
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The primary tumor is located in the middle and lower of the esophagus.
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cT2-4aN0～3M0 or cT1N+M0 diagnosed by enhanced CT/MRI scan.
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Tumor was evaluated as resectable by surgeon before neoadjuvant therapy.
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Eastern cooperative oncology group (ECOG) performance status of 0 to 1.
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Can eat semi-liquid food.
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Less than 20% body weight loss within 6 months prior to enrollment.
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Sign the consent form before treatment and be able to comply with the relevant procedures such as treatment and visits stipulated in the protocol.
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With adequate organs function 1 week before enrollment and tolerable to chemotherapy and surgery.
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Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age should take effective contraceptive measures throughout the treatment period and 180 days after the last dose of the test drug.
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Agree and be able to provide archived or fresh pathological tissue and whole blood, urine and fecal samples for biomarker testing.
Exclusion Criteria:
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With metastases or unresectable primary lesion suggested by imaging before treatment.
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History of previous subtotal gastrectomy.
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Patients with active malignancy within 2 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer.
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Received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy.
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With signs of pre-esophageal perforation. With any active autoimmune disease or has a history of autoimmune disease.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fudan University Shanghai Cancer Center | Shanghai | Shanghai | China | 200032 |
Sponsors and Collaborators
- Fudan University
- Innovent Biologics (Suzhou) Co. Ltd.
Investigators
- Principal Investigator: Haiquan Chen, MD, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ECTOP-2006