Sintilimab Combined With Chemotherapy Induction Therapy Followed by CCRT vs. CCRT for Esophageal Cancer: A Randomized Controlled Phase Ⅲ Clinical Study

NCT ID: NCT07306663

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2028-06-01

Brief Summary

The objective of this clinical trial is to determine whether the addition of immunotherapy combined with chemotherapy before chemoradiotherapy can increase the survival rate of patients with esophageal cancer. It will also assess the safety of this regimen. The primary questions it aims to answer include:

• Can the addition of immunotherapy combined with chemotherapy before chemoradiotherapy reduce the rate of disease recurrence among participants?
• What adverse reactions will participants experience during the treatment process?
• Compared with traditional chemoradiotherapy, will this regimen extend the survival period of participants?

Participants will:

• Undergo two cycles of immunotherapy combined with chemotherapy, administered every three weeks, followed by concurrent chemoradiotherapy, which includes 28 sessions of radiotherapy and five sessions of chemotherapy during the concurrent period; or proceed directly to concurrent chemoradiotherapy, and then receive two cycles of chemotherapy after the completion of radiotherapy, administered once a month.
• Undergo regular tests and examinations to evaluate efficacy and safety.
• Record symptoms that occur during the treatment period.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Induction group

Patients receive induction therapy with sintilimab plus 3-weekly paclitaxel/carboplatin for 2 cycles, followed by concurrent chemoradiotherapy (weekly paclitaxel/carboplatin plus radiotherapy).

Group Type: EXPERIMENTAL

Sintilimab

Intervention Type: BIOLOGICAL

200mg, once every three weeks, administered before concurrent chemoradiotherapy.

3-Weekly Paclitaxel plus Carboplatin (TC) Chemotherapy

Intervention Type: DRUG

Three-weekly induction chemotherapy regimen: Paclitaxel (135 mg/m², d1) + Carboplatin (AUC=5, d1), administered every 21 days.

Weekly TC Chemotherapy

Intervention Type: DRUG

Paclitaxel (50 mg/m², intravenous infusion on Day 1 of each week) combined with Carboplatin (AUC 2, intravenous infusion on Day 1 of each week), administered for 5 consecutive weeks as part of concurrent chemoradiotherapy.

Definitive Radiotherapy

Intervention Type: RADIATION

Definitive radiotherapy administered at a total dose of 50.4 Gy in 28 daily fractions (1.8 Gy per fraction) over approximately 5.5 weeks, delivered concurrently with weekly chemotherapy.

Standard group

Patients receive concurrent chemoradiotherapy (weekly paclitaxel/carboplatin with radiotherapy), followed by 2 cycles of consolidation chemotherapy (4-weekly paclitaxel/carboplatin).

Group Type: ACTIVE_COMPARATOR

Weekly TC Chemotherapy

Intervention Type: DRUG

Paclitaxel (50 mg/m², intravenous infusion on Day 1 of each week) combined with Carboplatin (AUC 2, intravenous infusion on Day 1 of each week), administered for 5 consecutive weeks as part of concurrent chemoradiotherapy.

Four-Weekly TC Consolidation Chemotherapy

Intervention Type: DRUG

Four-weekly consolidation chemotherapy regimen: Paclitaxel (175 mg/m², intravenous infusion on Day 1) combined with Carboplatin (AUC 5, intravenous infusion on Day 1), administered every 28 days for 2 cycles following concurrent chemoradiotherapy.

Definitive Radiotherapy

Intervention Type: RADIATION

Definitive radiotherapy administered at a total dose of 50.4 Gy in 28 daily fractions (1.8 Gy per fraction) over approximately 5.5 weeks, delivered concurrently with weekly chemotherapy.

Interventions

Sintilimab

200mg, once every three weeks, administered before concurrent chemoradiotherapy.

Intervention Type: BIOLOGICAL

3-Weekly Paclitaxel plus Carboplatin (TC) Chemotherapy

Three-weekly induction chemotherapy regimen: Paclitaxel (135 mg/m², d1) + Carboplatin (AUC=5, d1), administered every 21 days.

Intervention Type: DRUG

Weekly TC Chemotherapy

Paclitaxel (50 mg/m², intravenous infusion on Day 1 of each week) combined with Carboplatin (AUC 2, intravenous infusion on Day 1 of each week), administered for 5 consecutive weeks as part of concurrent chemoradiotherapy.

Intervention Type: DRUG

Four-Weekly TC Consolidation Chemotherapy

Four-weekly consolidation chemotherapy regimen: Paclitaxel (175 mg/m², intravenous infusion on Day 1) combined with Carboplatin (AUC 5, intravenous infusion on Day 1), administered every 28 days for 2 cycles following concurrent chemoradiotherapy.

Intervention Type: DRUG

Definitive Radiotherapy

Definitive radiotherapy administered at a total dose of 50.4 Gy in 28 daily fractions (1.8 Gy per fraction) over approximately 5.5 weeks, delivered concurrently with weekly chemotherapy.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Voluntarily participate and provide written informed consent;

2. Age 18-75 years, regardless of gender;

3. Histologically or cytologically confirmed esophageal squamous cell carcinoma;

4. Patients with inoperable esophageal cancer;

5. Clinical stage Ⅱ-ⅣA (AJCC 8th edition esophageal cancer staging system, including stage ⅣB with supraclavicular lymph node metastasis but excluding other distant metastatic stage ⅣB);

6. ECOG performance status 0-1;

7. Expected survival ≥ 3 months;

8. No severe dysfunction of hematopoietic, cardiac, pulmonary, hepatic, or renal systems, nor immune deficiency; Neutrophils ≥ 1.5×10⁹/L; hemoglobin ≥ 9 g/dL; platelets ≥ 100×10⁹/L; total bilirubin ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; creatinine ≤ 1.5 × ULN.

Exclusion Criteria

1. Esophageal perforation or hematemesis;

2. Active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (patients with hypothyroidism stable on hormone replacement therapy for ≥4 weeks with TSH/FT4 within normal range may be included); additionally, patients who have used immunosuppressants within 28 days will be excluded, except for steroid use for managing chemoradiation-related toxicities;

3. Previous or ongoing treatment with other types of PD-1 antibodies, or prior immunotherapy targeting PD-1/PD-L1;

4. Known allergic reaction to macromolecular protein drugs or sintilimab or any of its formulation components;

5. Uncontrolled cardiac disease or clinical symptoms, such as: a. heart failure of NYHA class II or above; b. unstable angina; c. myocardial infarction within the past year; d. supraventricular or ventricular arrhythmias requiring clinical intervention;

6. Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10⁴ copies/mL), hepatitis C (positive HCV antibody with HCV-RNA above the lower limit of detection), or active tuberculosis;

7. Active infection, or unexplained fever (body temperature >38.5℃) within 2 weeks prior to screening (fever judged by the investigator to be due to the tumor itself may be allowed);

8. Male or female participants of childbearing potential who refuse to use contraception during the study; or female patients who are pregnant or breastfeeding;

9. Other conditions judged by the investigator that may lead to premature termination of the study, such as co-existing severe diseases (including psychiatric disorders) requiring combined treatment, or family/social factors that may affect participant safety or integrity of the trial data.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Bethune Charitable Foundation

UNKNOWN

Sponsor Role: collaborator

Jiangsu Cancer Institute & Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ye jinjun

Chief Physician, Department of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinjun Ye

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Cancer Institute & Hospital

Locations

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

ESO-Nanjing7

Identifier Type: -

Identifier Source: org_study_id