Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Affiliated Cancer Hospital of Shantou University Medical College | OTHER |
Not provided
Not provided
Not provided
Not provided
The primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NCRT+IO group | Experimental | • NCRT+IO group consists of the PD-1 inhibitor combined with concurrent chemoradiotherapy prior to surgery. The patient will receive 4 weeks of radiation therapy. The radiation will generally commence on the 1st day of treatment and will run for 4 weeks.PD-1 inhibitor is given by intravenous infusion on days 1 and 22. Chemotherapy is given by intravenous infusion on days 1, 8, 15, and 22. Interventions:
|
|
| NCRT group | Active Comparator | • NCRT group consists of the concurrent chemoradiotherapy prior to surgery. The patient will receive 4 weeks of radiation therapy. The radiation will generally commence on the 1st day of treatment and will run for 4 weeks. Chemotherapy is given by intravenous infusion on days 1, 8, 15, and 22. Interventions:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | Sintilimab 200mg, IV (in the vein) on day 1 and day 22 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival will be calculated from the date of randomization and an event registered on the date of death from any cause. Patients lost to follow up, or those with no death recorded on the day the database is frozen, will be censored on the date of last follow up. | At end of enrollment- up to 5 years in follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Progression free survival is defined as the time from randomization until objective tumor progression or death. | At end of enrollment- up to 5 years in follow up |
| Pathologic complete response rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HONG YANG, M.D. Ph.D. | Contact | 8602087343 | 8602087343 | yanghong@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| HONG YANG | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Preoperative radiotherapy |
| Radiation |
External radiation with a total dose of 40.0 or 45.0 Gy is given in 20 fractions,5 fractions a week. |
|
| Paclitaxel | Drug | 50mg/m2, IV (in the vein) on day 1,day 8,day 15 and day 22 |
|
|
| Cisplatin | Drug | 25mg/m2,IV DRIP on day 1,day 8,day 15 and day 22 |
|
|
| esophagectomy | Procedure | McKeown esophagectomy, Ivor Lewis esophagectomy or minimally invasive esophagectomy will be performed 6-8 weeks after chemoradiotherapy. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery. |
|
No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes
| Two weeks after surgery |
| R0 resection rate | The percentage of patients who undergo complete resection | Two weeks after surgery |
| Incidence of perioperative complications | Incidence of complications | Ninety days after surgery |
| Perioperative mortality | Incidence of death postoperatively | Ninety after surgery |
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000632826 | sintilimab |
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| D016629 | Esophagectomy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided