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This is a randomized, double-blind, placebo-controlled Phase II/III clinical trial to evaluate the perioperative treatment with QL1706 in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma. The primary objective of the Phase II is to evaluate the pathological complete response rate of QL1706 perioperative treatment in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma; the primary objective of the Phase III is to compare event-free survival of QL1706 perioperative treatment in combination with neoadjuvant chemotherapy versus placebo in combination with neoadjuvant chemotherapy for locally advanced resectable esophageal squamous cell carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1706 injection combined with chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iparomlimab and Tuvonralimab (QL1706)Injection | Drug | PD-1/CTLA-4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic complete response rate (pCR) as assessed by the investigator; (Phase II stage) | pCR rate was defined as the percentage of subjects with no tumor residue in the primary tumor and regional lymph nodes. | 30 days after operation |
| Event-Free Survival (EFS) as assessed by BIRC; (Phase III stage) | EFS is defined as the time from randomization (for Phase II: from first dose) to the occurrence of an imaging disease progression/recurrence or death event from any cause, whichever occurs first. | up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Shen, M.D | Contact | 010-88196340 | doctorshenlin@sina.cn |
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| Paclitaxel | Drug | Chemotherapy |
|
| Cisplatin | Drug | Chemotherapy |
|
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| 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 |
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