Neoadjuvant CRT Combined With Camrelizumab and Nimotuzumab for Initially Inoperable Patients With Esophageal Carcinoma

NCT05355168 | Completed Phase 2

• 1 other identifier: 2021-ky238
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Neoadjuvant chemoradiotherapy followed by surgery has been the standard modality for locally advance esophageal carcinoma. According to CROSS study, the pathological complete remission rate achieved by paclitaxel and carboplatin with 41.4 Gy/23f was 49% for esophageal squamous cell carcinoma. But the 10-year overall survival rate was only 38%. How to increase the overall survival of esophageal carcinoma is a pivotal task. Both of Camrelizumab and Nimotuzumab have been demonstrated to be efficacious in the neoadjuvant treatment for esophageal squamous cell carcinoma in some small sample-size trials. Therefore, this trial is designed to combine adjuvant chemoradiotherapy with Camrelizumab and Nimotuzumab for resectable \& potentially resectable locally advanced esophageal squamous cell carcinoma and explore the safety and primary efficacy of such combination.

Conditions

Toxicity, Drug

Keywords

Esophageal squamous cell carcinoma; neoadjuvant chemoradiotherapy; nimotuzumab; camrelizumab

Outcome Measures

Primary Outcomes (1)

• 1-year progression free survival (PFS) rate

  1-year progression free survival (PFS) rate

  0 month post neoadjuvant treatment

Secondary Outcomes (5)

• Rate of adverse events

  1 to 2years

• Pathological complete remission rate

  0 month post surgery

• 1-, 2-year overall survival rate .

  1 to 2years

• Major pathological remission rate

  0 month post surgery

• surgical conversion rate

  0 month post neoadjuvant

Study Arms (1)

Neoadjuvant treatment

EXPERIMENTAL

Neoadjuvant chemoradiotherapy combined with Camrelizumab and Nimotuzumab

Drug: neoadjuvant chemoradiotherapy combined with Camrelizumab and Nimotuzumab followed by surgery

Interventions

neoadjuvant chemoradiotherapy combined with Camrelizumab and Nimotuzumab followed by surgery DRUG

neoadjuvant chemoradiotherapy combined with Camrelizumab and Nimotuzumab followed by surgery

Neoadjuvant treatment

Eligibility Criteria

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

You may qualify if:

• years old;
• Eastern Cooperative Oncology Group (ECOG) 0-1;
• Esophageal squamous cell carcinoma;
• cT2-4aN0-3M0-1a (AJCC 8th) confirmed by radiological examination;
• Initially inoperable at initial diagnosis confirmed by thoracic surgeons;
• No esophageal hemorrhage and no esophageal fistula at initial diagnosis;
• Treatment naive;
• No contraindications for adjuvant chemoradiotherapy, camrelizumab and nimotuzumab;
• Signature of inform consent.

You may not qualify if:

• younger than 18 years old or older than 75 years old;
• ECOG\>1;
• Esophageal adenocarcinoma, small-cell cancer and other pathological types;
• Presence of esophageal hemorrhage and esophageal fistula at initial diagnosis;
• Previous treatment of chemotherapy, radiotherapy, immune therapy and other treatment;
• Contraindications for chemoradiotherapy, camrelizumab and nimotuzumab;
• No signature of inform consent.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Anhui Provicial Hospital

Hefei, Anhui, China

Location

Related Publications (1)

• He Y, Liu H, Li X, Wang J, Wu H, Zhou H, Wang X, Cheng J, Ma J, Mei X, Tian J, Qian D. Neoadjuvant chemoradiation with camrelizumab and nimotuzumab for initially inoperable esophageal squamous cell carcinoma: A single-arm phase 2 trial. Eur J Cancer. 2025 Oct 1;228:115717. doi: 10.1016/j.ejca.2025.115717. Epub 2025 Aug 15.

  PMID: 40834785 DERIVED

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions; Esophageal Squamous Cell Carcinoma

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: To enroll 35 initially inoperable patients with locally advanced esophageal squamous cell carcinoma to receive neoadjuvant chemoradiotherapy combined with Camrelizumab and Nimotuzumab followed by surgery.

Study Record Dates

• First Submitted: April 16, 2022
• First Posted: May 2, 2022
• Study Start: November 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)