## Protocol Section
### Identification Module
**NCT ID:** NCT06429839

**Brief Title:** Nimotuzumab Concurrent With Chemoradiotherapy for Esophageal Cancer Patients

**Official Title:** Nimotuzumab Concurrent With Chemoradiotherapy for Elderly or Malnourished Patients With Unresectable Esophageal Squamous Cell Carcinoma: A Phase II Study

#### Organization Study ID Info
**ID:** NCC4571
#### Organization
**Class:** OTHER
**Full Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences
### Status Module
#### Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-03-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences

#### Responsible Party

**Investigator Affiliation:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences

**Investigator Full Name:** XIN WANG

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Elderly or malnourished patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) had poor prognosis. Radiotherpy was an important and effective treatment in treating ESCC. The present study is a one-arm trial that seeks to evaluate the efficacy in patients with unresectable ESCC. The study objectives include R0 resection rate, complete pathological response and treatment toxicity, etc.

Nimotuzumab is a recombinant humanized monoclonal antibody against EGFR. Its efficacy and safety in patients with esophageal cancer have been confirmed by many studies.

The current prospective phase II study aimed to evaluate the efficacy and safety of a combination regimen comprising chemotherapy with nimotuzumab with a dose of 800mg per week and S-1 and concurrent radiotherapy for patients who are elderly or malnourished.

### Conditions Module

**Conditions:**

- Esophageal Cancer

- Nimotuzumab

- Chemoradiotherapy

- Chemotherapy

- Immunotherapy

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 55

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Combination Product: Nimotuzumab with chemoradiotherapy

**Label:** Nimotuzumab concurrent with chemordiotherapy followed by surgery

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Nimotuzumab concurrent with chemordiotherapy followed by surgery

**Description:** Radiotherapy,40-50.4Gy/20-28f. Nimotuzumab 400mg,ivgtt,W2d. Chemotherapy, S-1,40-60mg/m2, on BSA, orally twice daily on radiotherapy days.

**Name:** Nimotuzumab with chemoradiotherapy

**Type:** COMBINATION_PRODUCT

### Outcomes Module

#### Primary Outcomes

**Description:** Minimal distance tumor/circumferential resection margin (CRM) \> 1 mm.

**Measure:** R0 resection rate

**Time Frame:** 4 months after initiation of induction chemoimmunotherapy

#### Secondary Outcomes

**Description:** the complete remission of all viable cancer cells in any of the specimens from surgery, including the primary site and lymph nodes

**Measure:** Pathological complete response

**Time Frame:** 4 months after initiation of induction chemoimmunotherapy

**Description:** the time from start of chemoradiotherapy to 1 month after chemoradiotherapy

**Measure:** Event-free survival

**Time Frame:** 1 month after chemoradiotherapy

**Measure:** Postoperative complications

**Time Frame:** 1 month after surgery

**Description:** the time from start of induction chemo(immuno)therapy to all-cause death, or the last day of follow-up

**Measure:** Overall survival

**Time Frame:** 1 year after all treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Histologically confirmed esophageal squamous cell carcinoma.
* No previous treatment for the esophageal carcinoma.
* KPS score ≥70.
* NRS-2002 score≥2.
* Main organs and bone marrow function are normal: routine blood tests: hemoglobin (Hb) ≥100g/L ; absolute neutrophil count (NEUT)≥1.5×109/L; platelets (PLT) ≥100×109/L; white blood cell (WBC)≥3.5×109/L,biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×UNL; serum total bilirubin (TBIL) ≤1.5×UNL; serum creatinine ( Cr) 1.0×1.5UNL, and BUN≤1.0×UNL;

Exclusion Criteria:

* Previous treatment of the esophageal cancer with surgery, radiation, or chemotherapy.
* Those combined with other primary malignant tumors other than esophageal cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
* At the time of diagnosis, there were distant and hematogenous metastases beyond the supraclavicular lymph node region, including retroperitoneal multiple lymph node metastasis, bone metastasis, brain metastasis, lung metastasis, liver metastasis, malignant pleural effusion and ascites
* There are active infections, such as active tuberculosis and hepatitis
* There are contraindications to targeted therapy.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** beryl_wx2000@163.com

**Name:** Xin Wang, Doctor

**Phone:** 13311583220

**Role:** CONTACT

**Contact 2:**

**Email:** fenggj18243017306@163.com

**Name:** Guojie Feng, B.M

**Phone:** 16601212285

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** berly_wx2000@163.com

- **Name:** Xin Wang, Doctor

- **Phone:** 13311583220

- **Role:** CONTACT

**Country:** China

**Facility:** National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

**Status:** RECRUITING

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000006258

- Term: Head and Neck Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000004935

- Term: Esophageal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M5550

- Name: Carcinoma, Squamous Cell

- Relevance: LOW

- As Found: Unknown

- ID: M8088

- Name: Esophageal Neoplasms

- Relevance: HIGH

- As Found: Esophageal Cancer

- ID: M25306

- Name: Malnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M1733

- Name: Esophageal Squamous Cell Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M9348

- Name: Head and Neck Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8085

- Name: Esophageal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T2141

- Name: Esophageal Cancer

- Relevance: HIGH

- As Found: Esophageal Cancer

### Condition Browse Module - Meshes

- ID: D000004938

- Term: Esophageal Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M288889

- Name: Nimotuzumab

- Relevance: HIGH

- As Found: Details

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000501466

- Term: Nimotuzumab

### Misc Info Module

- Version Holder: 2024-05-31
