## Protocol Section
### Identification Module
**NCT ID:** NCT06421376

**Brief Title:** Induction Chemoimmunotherapy Combined With Chemoradiotherapy in Esophageal Cancer

**Official Title:** Efficacy and Safety of Inductive Chemoimmunotherapy Followed by Chemoradiotherapy With or Without Surgery in Locally Advanced Esophageal Squamous Cell Cancer: a Single-arm, Prospective, Phase II Trial

#### Organization Study ID Info
**ID:** NCC4475
#### Organization
**Class:** OTHER
**Full Name:** Cancer Institute and Hospital, Chinese Academy of Medical Sciences
### Status Module
#### Completion Date
**Date:** 2027-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-14
### 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:** Jianjun Qin

**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:** Although unprecedented advances have been made in the field of esophageal cancer in recent decades, the prognosis for patients with locally advanced esophageal squamous cell carcinoma (ESCC) remains extremely poor, accounting for 30-40% of overall survival at 5 year. In recent years, multimodal treatments have proven to be an appropriate therapeutic approach for locally advanced ESCC. Recently, immunotherapy developed rapidly. The purpose of this study was to observe the efficacy and safety of cardonilizumab combined with chemoradiotherapy in the treatment of locally advanced ESCC.

### Conditions Module

**Conditions:**

- Esophageal Cancer

- Immunotherapy

- Induction Therapy

- Chemoradiotherapy

- Surgery

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In this group, the patients were given 2 cycles of inductive therapy of cardonilizumab combined with chemotherapy, followed by concurrent chemoradiotherapy with two cycles of nab-paclitaxel and cisplatin plus radiotherapy of 50-50.4 Gy. After clinical evaluation, surgery was feasible for a part of patients.

**Intervention Names:**

- Drug: Cardonilizumab

- Radiation: Chemoradiotherapy ±immunotherapy

- Procedure: Radical surgery

**Label:** Inductive chemoimmunotherapy+chemoradiotherapy±surgery

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Inductive chemoimmunotherapy+chemoradiotherapy±surgery

**Description:** Two cycles of Inductive therapy： nab-paclitaxel 250mg/ m2+cisplatin 75mg/ m2+Cardonilizumab 10mg/kg，ivgtt，3 weeks per cycle for 2 cycles

**Name:** Cardonilizumab

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Inductive chemoimmunotherapy+chemoradiotherapy±surgery

**Description:** Chemoradiotherapy ± immunotherapy：

* PTV: 50-50.4Gy/1.8-2Gy/25-28fractions ②nab-paclitaxel 100mg+cisplatin 25mg/ m2, d1, every 7 days for 3-5 weeks ③Cardonilizumab 10mg/kg，ivgtt，3 weeks per cycle for 2 cycles

**Name:** Chemoradiotherapy ±immunotherapy

**Type:** RADIATION

#### Intervention 3

**Arm Group Labels:**

- Inductive chemoimmunotherapy+chemoradiotherapy±surgery

**Description:** Surgery was evaluated after concurrent chemoradiotherapy according to patients willing and the surgeons' assessment. If patients were accessed with unresectable disease after radiotherapy or refused to receive surgery, Cardonilizumab would be administered for 2 years or until disease progression.

**Name:** Radical surgery

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Time from treatment initiation to locoregional or distant recurrence, or death from any cause.

**Measure:** Event-free survival

**Time Frame:** 1-year

#### Secondary Outcomes

**Description:** The 1-year OS rate was defined as the proportion of patients who still alive within one year from treatment initiation.

**Measure:** Overall survival

**Time Frame:** 1-year

**Description:** In terms of adverse events of radiation, chemotherapy and immunotherapy

**Measure:** Adverse events

**Time Frame:** 1-year

**Description:** The 1-year rate was defined as the proportion of patients who did not have any locoregional recurrence from treatment initiation.

**Measure:** Locoregional recurrence free survival

**Time Frame:** 1-year

**Description:** The 1-year rate was defined as the proportion of patients who did not have any distant metastasis from treatment initiation.

**Measure:** Distant metastasis free survival

**Time Frame:** 1-year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 18-80 years old；
* Eligible patients were histologically confirmed esophageal squamous cell carcinoma;
* Eligible patients were proven locally advanced ESCC (cT1-2N1-3M0-1, cT3/T4N0-3M0-1, M1 was limited to supraclavicular lymph node metastasis）diagnosed by computed tomography \[CT\] and/or endoscopic ultrasonography \[EUS\] according to the American Joint Committee on Cancer (AJCC) 8th edition staging system；
* ECOG PS score: 0\~1；
* 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:

* 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);
* patients who had previously received other treatments
* 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
* Those who already have esophageal perforation or are at high risk of esophageal perforation
* Patients whose tumors invade close to large blood vessels and are at risk of bleeding in the
* there are active infections, such as active tuberculosis and hepatitis
* There are contraindications to immunotherapy.
* Pregnant or lactating women and women of childbearing age do not take reliable contraceptive measures
* Combined with serious cardiovascular diseases, such as uncontrolled heart failure, coronary heart disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or a history of myocardial infarction within the past 6 months; and those combined with other uncontrolled acute and chronic diseases such as hypertension and diabetes.
* Violation of inclusion and exclusion criteria, or other reasons that the researcher believes cannot continue the study of drug treatment.

**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, M.D.

**Phone:** +861013311583220

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Anyang

**Contacts:**

***Contact 1:***

- **Name:** Xiaomin Wang, M.D.

- **Role:** CONTACT

**Country:** China

**Facility:** Anyang Cancer Hospital

**State:** Henan

**Status:** NOT_YET_RECRUITING

**Location 2:**

**City:** Xinxiang

**Contacts:**

***Contact 1:***

- **Name:** Xiaomei Liu, M.D.

- **Role:** CONTACT

**Country:** China

**Facility:** The First Affiliated Hospital of Xinxiang Medical University

**State:** Henan

**Status:** NOT_YET_RECRUITING

**Location 3:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** beryl_wx2000@163.com

- **Name:** Xin Wang, MD

- **Phone:** +861013311583220

- **Role:** CONTACT

**Country:** China

**Facility:** Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

**Status:** RECRUITING

**Zip:** 100021

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

**Name:** Xin Wang

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## 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: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5550

- Name: Carcinoma, Squamous Cell

- Relevance: LOW

- As Found: Unknown

- ID: M8088

- Name: Esophageal Neoplasms

- Relevance: HIGH

- As Found: Esophageal Cancer

- 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: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M19537

- Name: Paclitaxel

- Relevance: LOW

- As Found: Unknown

- ID: M231

- Name: Albumin-Bound Paclitaxel

- Relevance: LOW

- As Found: Unknown

- ID: M6182

- Name: Cisplatin

- Relevance: LOW

- As Found: Unknown

- ID: M2853

- Name: Immunomodulating Agents

- Relevance: HIGH

- As Found: CAR-

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000091369

- Term: Immunomodulating Agents

### Misc Info Module

- Version Holder: 2024-05-31
