Sintilimab Plus NCT or NCRT Versus NCRT for ESCC

NCT05244798 | Not Yet Recruiting Phase 3

• 1 other identifier: SCCH-TS2201
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

Comparative analysis of patients with resectable locally advanced esophageal squamous cell carcinoma treated with neoadjuvant chemotherapy or neoadjuvant chemoradiotherapy combined sintilimab versus neoadjuvant chemoradiotherapy.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Pathology complete response rate, pCR

  Definition of pathology complete response is "no cancer cell, including lympho nodes" which corresponds with tumor regression score 0 definition of pathologic response is as follows. Tumor regression score Grade 0 and 1 will be defined as "responder" and 2 and 3 will be considered as "non-responders".

  3 months after the surgery

Secondary Outcomes (9)

• Treatment related adverse event, TRAE

  3 months after the surgery

• Major Pathological Remission rate, MPR

  3 months after the surgery

• Rate of R0 resection

  3 months after the surgery

• Events Free Survival, EFS

  Through study completion, an average of 1 year.

• Overall Survival,OS

  5 years after inclusion

Study Arms (3)

Group of sintilimab combined with neoadjuvant chemotherapy

EXPERIMENTAL

sintilimab (D1 administration) was given in combination with chemotherapy (TP regimen: albumin-paclitaxel + carboplatin, D1 administration) for 2 cycles. Every 3 weeks, there was a dosing cycle (Q3W). Surgery was performed 6-8 weeks after completion of neoadjuvant therapy. If the patients without vital tumor cells in primary and lymph nodes after surgery, they only need regular follow-up visit. If the patients with non-pCR resected, those patients need to receive adjuvant immunotherapy. And if the patients with non-R0 resected, the regimen of those patients need to carefully decide based on multidisciplinary team discussed.

Drug: Sintilimab; Drug: Chemotherapy

Group of sintilimab combined with neoadjuvant chemoradiotherapy

EXPERIMENTAL

sintilimab (D1) was administered in combination with concurrent chemoradiotherapy. Chemotherapy regimen: TP regimen: albumin-paclitaxel + carboplatin, D1 administration, 2 cycles. Every 3 weeks, there was a dosing cycle (Q3W). Radiotherapy regimen: according to IMRT treatment plan, the total dose was 41.4Gy, divided into 23 times, 5 days a week. Surgery was performed 6-8 weeks after completion of neoadjuvant therapy. If the patients without vital tumor cells in primary and lymph nodes after surgery, they only need regular follow-up visit. If the patients with non-pCR resected, those patients need to receive adjuvant immunotherapy. And if the patients with non-R0 resected, the regimen of those patients need to carefully decide based on multidisciplinary team discussed.

Drug: Sintilimab; Radiation: radiotherapy; Drug: Chemotherapy

Group of neoadjuvant chemoradiotherapy

OTHER

The control group received neoadjuvant chemoradiotherapy and the regimen was as follows:Chemotherapy regimen: TP regimen: albumin paclitaxel + carboplatin, D1 administration, 2 cycles. Every 3 weeks, there was a dosing cycle (Q3W). Radiotherapy regimen: according to IMRT treatment plan, the total dose was 41.4Gy, divided into 23 times, 5 days a week. Surgery was performed 6-8 weeks after completion of neoadjuvant therapy. If the patients without vital tumor cells in primary and lymph nodes after surgery, they only need regular follow-up visit. If the patients with non-pCR resected, those patients need to receive adjuvant immunotherapy. And if the patients with non-R0 resected, the regimen of those patients need to carefully decide based on multidisciplinary team discussed.

Radiation: radiotherapy; Drug: Chemotherapy

Interventions

Sintilimab DRUG

Sintilimab: D1 administration) for 2 cycles. Every 3 weeks was a dosing cycle (Q3W)

Group of sintilimab combined with neoadjuvant chemoradiotherapy; Group of sintilimab combined with neoadjuvant chemotherapy

radiotherapy RADIATION

Radiotherapy: According to IMRT treatment plan, the total dose was 41.4Gy, divided into 23 times, 5 days a week.

Group of neoadjuvant chemoradiotherapy; Group of sintilimab combined with neoadjuvant chemoradiotherapy

Chemotherapy DRUG

Neoadjuvant chemotherapy with TP regimen: albumin-paclitaxel + carboplatin, D1 administration) for 2 cycles. Every 3 weeks was a dosing cycle (Q3W).

Group of neoadjuvant chemoradiotherapy; Group of sintilimab combined with neoadjuvant chemoradiotherapy; Group of sintilimab combined with neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 75, both sexes;
• Patients with histologically confirmed locally advanced (cT1N2-3M0 or cT2-4aN0-3M0) thoracic esophageal squamous cell carcinoma (8th UICC-TNM stage);
• Cervical contrast-enhanced CT showed no suspicious metastatic lymph nodes. Imaging examination showed no systemic metastasis.
• R0 resection is expected to be achieved;
• Physical state ECOG 0 \~ 1;
• No previous antitumor therapy for esophageal cancer, including chemotherapy, radiotherapy (including radiotherapy planned during the study), hormone therapy, and immunotherapy;
• Measurable lesions (according to RECIST v1.1);
• There was no operation contraindications in the evaluation of various organ functions before operation;
• The following laboratory tests confirm that the bone marrow, liver and kidney functions meet the requirements for study participation:
• Hemoglobin ≥90g/L;
• White blood cell count ≥ lower limit of laboratory normal;
• Neutrophil absolute value (ANC) ≥1.5×109/L;
• Platelet count ≥100×109/L; Total bilirubin ≤1.5× upper limit of normal (ULN);
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN;
• Prothrombin time ≤16 seconds and international normalized ratio ≤1.5×ULN; Creatinine ≤1.5×ULN or Cr clearance ≥50 mL/min (calculated using Cockcroft-Gault formula);

You may not qualify if:

• Patients who met any of the following criteria were excluded from the study:
• Malignant tumors other than esophageal cancer (cured localized tumors, including cervical carcinoma in situ, skin basal cell carcinoma and prostate carcinoma in situ, were not excluded) had occurred within 5 years before randomization; Prostate cancer patients receiving hormone therapy with DFS for more than 5 years were not excluded).
• Patients with high blood tendency who had a history of gastrointestinal bleeding within 6 months before randomization, or had coagulopathy at the time of enrollment, or were receiving thrombolysis or anticoagulant therapy;
• Severe cardiovascular and cerebrovascular diseases:
• New York Heart Association (NYHA) class II or higher congestive heart failure, unstable angina, myocardial infarction, poorly controlled arrhythmias, or cerebrovascular accidents within 12 months before randomization.
• LVEF (left ventricular ejection fraction) \<50% on echocardiography. Corrected QT interval (QTc) \>480ms (calculated using Fridericia's method; if QTc was abnormal, three consecutive tests were performed at 2 min intervals and the mean value was taken).
• Medically difficult to control hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100mmHg) (based on the average of ≥2 measurements).
• A previous hypertensive crisis or hypertensive encephalopathy.
• Previous history of interstitial lung disease or pneumonia requiring steroid treatment at enrollment;
• Had active tuberculosis at the time of randomization, or had received anti-tuberculosis therapy within 1 year before randomization;
• Asthma at random requiring intermittent use of bronchodilators or other medical interventions;
• Patients with infectious diseases requiring systemic treatment (oral or intravenous administration) within 4 weeks before randomization; for active hepatitis, effective treatment was required before enrollment;
• Severe unhealed wounds, active ulcers, and untreated fractures at random;
• Combined with other inoperable conditions;
• The previous operation resulted in the inability to use stomach instead of esophagus to reconstruct the digestive tract in this operation;

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead
• Peking University Cancer Hospital & Institute: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• Hebei Medical University Fourth Hospital: collaborator
• Anhui Provincial Hospital: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Anyang Tumor Hospital: collaborator
• Shantou Central Hospital: collaborator
• Innovent Biologics (Suzhou) Co. Ltd.: collaborator
• GeneCast Biotechnology Co., Ltd.: collaborator

Study Sites (1)

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

• He W, Bai H, Lv J, Tang P, Hu T, Zhou H, Xiao W, Peng L, Liu G, Wang K, Fang Q, Qi Y, Liang L, Zheng X, Qing H, Chen Y, Zhou Y, Xie W, Han Y, Leng X. Neoadjuvant chemotherapy or chemoradiotherapy plus sintilimab versus neoadjuvant chemoradiotherapy for locally advanced oesophageal squamous cell carcinoma: a study protocol of a multicentre, randomised, controlled, phase III trial (SCIENCE study). BMJ Open. 2025 Jun 4;15(6):e095828. doi: 10.1136/bmjopen-2024-095828.

  PMID: 40467307 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

sintilimab; Radiotherapy; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Yongtao Han, M.D.

CONTACT

18908178797; hanyongt@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Thoracic Surgery

Study Record Dates

• First Submitted: January 30, 2022
• First Posted: February 17, 2022
• Study Start: November 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)