Combination of Toripalimab and preoperative Neoadjuvant chemoradiation for esophageal squamous cell carcinoma

Safety and efficacy of Toripalimab combined with preoperative Neoadjuvant chemoradiation for resectable and potentially resectable III-IVA esophageal squamous cell carcinoma: a phase I/II single-arm exploratory clinical study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100042530

Enrollment

Unknown

Registered

2021-01-23

Start date

2021-03-01

Completion date

Unknown

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Combination of Toripalimab and preoperative Neoadjuvant chemoradiation:Toripalimab

Combination of Toripalimab and preoperative Neoadjuvant chemoradiation:Radiotherapy

Combination of Toripalimab and preoperative Neoadjuvant chemoradiation:Paclitaxel + Carboplatin

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. For subjects aged 18-70, PS score was 0-1; 2. Patients with pathologically proved thoracic esophageal squamous cell carcinoma who are considered resectable or potentially resectable by esophageal surgeons; 3. The first choice of preoperative PET-CT examination was chest and abdomen enhanced CT and bone scan. According to the eighth edition AJCC / UICC staging, it was stage III-IVA, specifically: T2N + (106rec group or abdominal 1, 2, 3, 7, 8, 9 groups of lymph node metastasis); T3-4a Any N M0 patients; 4. Patients whose expected survival time is more than half a year; 5. WBC >= 4.0 x 10^9/l, ANC >= 1.5 x 10^9 / L, platelet >= 100.0 x 10^9 / L, Hb >= 90 g / L, normal liver and kidney function; 6. Patients with general conditions or medical complications who can tolerate radiotherapy, chemotherapy and surgery; 7. Patients who understand and sign the informed consent form of this study.

Exclusion criteria

Exclusion criteria: 1. For the patients with supraclavicular lymph node metastasis (group 104), 106rec lymph nodes extended beyond the level of thoracic entrance to group 101, which was considered impossible by esophageal surgery experts; 2. Patients with previous history of malignant tumor, who have received radiotherapy and chemotherapy in the past.

Design outcomes

Primary

Measure	Time frame
Pathological complete remission rate;Main pathological response rate;R0 resection rate;1-year DFS rate;median DFS;	—

Countries

China

Contacts

Public ContactDong Qian

The First Affiliated Hospital of University of science and technology of China (Anhui Provincial Hospital)

qiankeyu@163.com+86 18202269589

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026