A Perioperative Sintilimab and Chemotherapy in Esophageal Squamous Cell Carcinoma
NCT ID: NCT06152978
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
182 participants
INTERVENTIONAL
2023-12-15
2027-12-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Sintilimab
Sintilimab (200mg) will be given intravenously on day 1 in 3-week cycles for 2-3 cycles.
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.
Chemotherapy
Cisplatin: 75mg/m2, d1, routine hydration for 3 days; nab-paclitaxel: 260mg/m2, d1, every 3 weeks, 2-3 cycles.
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.
Interventions
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Sintilimab
Sintilimab (200mg) will be given intravenously on day 1 in 3-week cycles for 2-3 cycles.
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.
Eligibility Criteria
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Inclusion Criteria
* The primary tumor is located in the middle and lower of the esophagus.
* cT2-4aN0～3M0 or cT1N+M0 diagnosed by enhanced CT/MRI scan.
* Tumor was evaluated as resectable by surgeon before neoadjuvant therapy.
* Eastern cooperative oncology group (ECOG) performance status of 0 to 1.
* Can eat semi-liquid food.
* Less than 20% body weight loss within 6 months prior to enrollment.
* Sign the consent form before treatment and be able to comply with the relevant procedures such as treatment and visits stipulated in the protocol.
* With adequate organs function 1 week before enrollment and tolerable to chemotherapy and surgery.
* 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.
* Agree and be able to provide archived or fresh pathological tissue and whole blood, urine and fecal samples for biomarker testing.
Exclusion Criteria
* History of previous subtotal gastrectomy.
* 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.
* 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.
* With signs of pre-esophageal perforation. With any active autoimmune disease or has a history of autoimmune disease.
18 Years
75 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Fudan University
OTHER
Responsible Party
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Haiquan Chen
Prof.
Principal Investigators
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Haiquan Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Haiquan Chen, MD
Role: primary
Other Identifiers
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ECTOP-2006
Identifier Type: -
Identifier Source: org_study_id