Clinical trial · Interventional
A Study of Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer
A Study of Anti-PD-1 Antibody, Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer
NCT03940001CI-TRIAL-00040476unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to test the the efficacy and safety of sintilimab in combination with chemoradiation before surgery for esophageal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin/paclitaxel | Drug | Carboplatin/Paclitaxel Regimen | ALIAS |
| Radiation | Radiation | — | UNRESOLVED |
| Sintilimab | Biological | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- arm
- description
- Biological: Sintilimab For weight \<60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1 Drug: Paclitaxel 50 mg/m\^2 IV Q3W day 1, day 8 and day 15 Drug: carboplatin AUC: 2 IV Q3W day 1, day 8 and day 15 Radiotherapy: 1.8 Gy/fraction ×23 fractions Monday to Friday total dose of 41.4 Gy
- interventionNames
- Biological: Sintilimab
- Drug: carboplatin/paclitaxel
- Radiation: Radiation
Primary outcomes (3)
- measure
- unacceptable toxicity
- timeFrame
- 1 year
- description
- "Unacceptable toxicity" is defined as any of the following toxicities: \>1 episode of grade 3/4 neutropenia or thrombocytopenia \<75,000/μL (despite prior dose reduction) during chemoradiation any toxicity that results in \>2 week cumulative delay in chemoradiation any toxicity that is attributed to durvalumab which results in a delay of \>8 weeks in surgery, i.e. surgery \>16 weeks from the end of radiation, for a potentially operable patient any reason that is attributed to durvalumab which leads to death within 30 days of surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed esophageal squamous carcinoma * 18≤age≤75 * ECOG PS is 0-1 * TanyN+M0 or T3-4NanyM0 tumors * Patients must have surgically resectable disease treatable by esophagectomy, as assessed by a thoracic surgeon * No prior chemotherapy,radiotherapy and immunotherapy * Disease must be clinically limited to the esophagus * No esophageal perforation and no active esophageal bleeding * No interstitial pneumonia or history of interstitial pneumonia * FEV1\>1.2L * Adequate organ function defined at baseline as: WBC ≥3,000/ L，ANC ≥1,500/ L，Platelets ≥100,000/ L，Hb ≥9 g/dl； Calculated creatinine clearance \>40 ml/min using Cockcroft-Gault method: Males: Creatinine CL = Weight (kg) x (140 - Age) . (mL/min) 72 x serum creatinine (mg/dL)Female：Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)；Total serum bilirubin ≤1.5 mg/dL， AST/ALT ≤2.5× upper limit of normal，Mean QT interval corrected for heart rate (QTc) \<470 ms calculated from 3 ECGs using Frediricia's Correction * Able to provide written informed consent * Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up Exclusion Criteria: * Previous treatment with chemotherapy, radiotherapy or immunotherapy * Cervical esophageal cancer * Esophageal perforation or active esophageal bleeding * Interstitial pneumonia or history of interstitial pneumonia * Patients with evidence of metastatic disease * Chronic Hepatitis B or C infection (e.g. Hepatitis B surface Ag positive or detectable viral load for Hepatitis B or C). Patients with prior evidence of Hepatitis B or C without active infection are eligible * Autoimmune diseases (such as systemic lupus erythematosus, rheumatoid rthritis, inflammatory bowel disease, autoimmune thyroid disease), but allow the following diseases to enter the next stage of screening: type I diabetes, skin diseases without systemic treatment (such as vitiligo, psoriasis) * 14 days before the first dose, the patient had an active infection that required systemic treatment * Inability to understand or may not comply with test requirements
References
Publications (1)
- DERIVEDShen D, Li R, She Y, Liu X, Huang Y, Ji Y, Chen K, Song Z, Chen R, Li X, Zhao Q, Chen Q, Chen M. PRDM1+ Malignant Cells Mediate an Immunosuppressive Landscape and Resistance to Neoadjuvant Chemoradiotherapy and Immunotherapy in Esophageal Squamous Cell Carcinoma. Adv Sci (Weinh). 2026 Mar;13(17):e15207. doi: 10.1002/advs.202515207. Epub 2026 Jan 20. PMID 41556358