## Protocol Section
### Identification Module
**NCT ID:** NCT06228079

**Brief Title:** Adjuvant vs Surgery Only in Early-stage Recurrent NPC

**Official Title:** Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial

#### Organization Study ID Info
**ID:** early-rNPC-RCT-adj
#### Organization
**Class:** OTHER
**Full Name:** Eye & ENT Hospital of Fudan University
### Status Module
#### Completion Date
**Date:** 2028-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-01-18

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2028-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2024-01-29
**Type:** ACTUAL
**Study First Submit Date:** 2023-12-21
**Study First Submit QC Date:** 2024-01-18
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Shanghai Zhongshan Hospital

**Class:** OTHER

**Name:** Shanghai 6th People's Hospital

**Class:** OTHER

**Name:** Changhai Hospital

**Class:** OTHER

**Name:** Fujian Medical University Union Hospital

**Class:** OTHER

**Name:** People's Hospital of Guangxi

**Class:** OTHER

**Name:** Shenzhen Second People's Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Eye & ENT Hospital of Fudan University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial

**Detailed Description:** This study is an open-label, multicentered, evaluator-blinded , randomized clinical trial.

Patients with early-stage recurrent nasopharyngeal carcinoma were randomized into the control group and the experimental group. Patients in the control group would go through observation and follow-up after recurrent endoscopic surgery, while patients in the experimental group would be treated with adjuvant therapy such as chemotherapy and immunotherapy. A total of 176 subjects are required, with 88 patients in the control group and 88 patients in the experimental group.

### Conditions Module

**Conditions:**

- Recurrent Nasopharyngeal Carcinoma

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 176

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients in the control group would go through observation and follow-up after recurrent endoscopic surgery.

**Label:** The control group

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** Patients in the experimental group would be implemented with adjuvant therapy including chemotherapy and immunotherapy after endoscopic surgery.

**Intervention Names:**

- Drug: Immunotherapy,Toripalimab Injection

- Drug: Chemotherapy,Gemcitabine based regimen

**Label:** The experimental group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- The experimental group

**Description:** Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.

**Name:** Immunotherapy,Toripalimab Injection

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- The experimental group

**Description:** Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.

**Name:** Chemotherapy,Gemcitabine based regimen

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Disease free survival

**Measure:** DFS

**Time Frame:** From date of randomization until the date of first documented recurrence, metastasis or date of death from any cause, whichever came first, assessed up to 24 months

#### Secondary Outcomes

**Description:** Overall Survival

**Measure:** OS

**Time Frame:** From randomization to death of any cause,assessed up to 60 months

**Description:** Local recurrence free survival

**Measure:** LRFS

**Time Frame:** From randomization to local recurrence or death,assessed up to 24 months

**Description:** Distant metastasis free survival

**Measure:** DMFS

**Time Frame:** From randomization to distant metastasis or death, assessed up to 24 months

**Description:** one- and two-year disease free survival

**Measure:** 1-and 2-year DFS rate

**Time Frame:** end of 1st year, end of 2nd year

**Description:** one- and two-year overall survival rate

**Measure:** 1-and 2-year OS rate

**Time Frame:** end of 1st year, end of 2nd year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
2. Stage rT1 or rT2(superficial parapharyngeal space, distance to internal carotid artery ≤5mm)or rT3 (confined to the bottom wall of the sphenoid sinus),according to AJCC 8th edition;
3. Cervical lymph node metastasis can be controlled locally
4. Age 18 to 70 years;
5. Without distant metastasis;
6. Informed consent forms signed;
7. ≥6months from the accomplishment of radiation to recurrence
8. previously radiotherapy for only 1 course;
9. ECOG score 0-2 and can tolerate chemotherapy and immunotherapy
10. Sufficient organ function;
11. Undergone endoscopic surgery with negative pathological margin;

Exclusion Criteria:

1. Participation in other interventional clinical trials;
2. Uncontrolled illnesses which will interfere with the ability to undergo therapy;
3. Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ);
4. Any contradiction to immune and chemotherapy;
5. With serious autoimmune disease;
6. Currently usage of immunosuppressive agents or systemic glucocorticoid therapy (dosage\>10mg/day prednisone or other glucocorticoids), and continuing to use them within 2 weeks before the first administration of trial drugs;
7. Severe allergic reactions to other monoclonal antibodies;
8. Previously treatment with PD-1 monoclonal antibody, PD-L1 monoclonal antibody, CTLA-4 monoclonal antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway);
9. History of radioactive particle planting;
10. Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period;
11. Female patients who are at pregnancy or lactation;
12. Other situations that the researchers believe are not suitable for enrollment

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jxfxsxl@163.com

**Name:** Xiaole Song, MD

**Phone:** +8621 64377134

**Role:** CONTACT

**Contact 2:**

**Name:** Yuting Lai

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shanghai

**Country:** China

**Facility:** Eye& ENT Hospital, Fudan University

**State:** Shanghai

**Zip:** 200031

**Location 2:**

**City:** Fuzhou

**Contacts:**

***Contact 1:***

- **Name:** Desheng Wang

- **Role:** CONTACT

***Contact 2:***

- **Name:** Desheng Wang

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Haichun Lai

- **Role:** SUB_INVESTIGATOR

**Country:** China

**Facility:** Fujian Medical University Union Hospital

**Location 3:**

**City:** Nanning

**Contacts:**

***Contact 1:***

- **Name:** Shenhong Qu

- **Role:** CONTACT

***Contact 2:***

- **Name:** Shenhong Qu

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Jingjin Weng

- **Role:** SUB_INVESTIGATOR

**Country:** China

**Facility:** The People's Hospital of Guangxi Zhuang Autonomous Region

**Location 4:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Name:** Haihong Tang

- **Role:** CONTACT

***Contact 2:***

- **Name:** Haihong Tang

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Hongliang Zheng

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Haopu Li

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Fengya Pan

- **Role:** SUB_INVESTIGATOR

**Country:** China

**Facility:** Changhai Hospital

**Location 5:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Name:** Weitian Zhang

- **Role:** CONTACT

***Contact 2:***

- **Name:** Weitian Zhang

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Ru Tang

- **Role:** SUB_INVESTIGATOR

**Country:** China

**Facility:** Shanghai Sixth People's Hospital

**Location 6:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Name:** Xinsheng Huang

- **Role:** CONTACT

***Contact 2:***

- **Name:** Xinsheng Huang

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Xianhui Ning

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Lei Zhou

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Shanghai Zhongshan Hospital

**Location 7:**

**City:** Shenzhen

**Contacts:**

***Contact 1:***

- **Name:** Yongtian Lu

- **Role:** CONTACT

***Contact 2:***

- **Name:** Yongtian Lu

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Jing Tao

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Shenzhen Second People's Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** Eye& ENT Hospital, Fudan University

**Name:** Hongmeng Yu

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Info Types:**

- STUDY_PROTOCOL

- ICF

- CSR

**IPD Sharing:** YES

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009303

- Term: Nasopharyngeal Neoplasms

- ID: D000010610

- Term: Pharyngeal Neoplasms

- ID: D000010039

- Term: Otorhinolaryngologic Neoplasms

- ID: D000006258

- Term: Head and Neck Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009302

- Term: Nasopharyngeal Diseases

- ID: D000010608

- Term: Pharyngeal Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000010038

- Term: Otorhinolaryngologic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M14850

- Name: Recurrence

- Relevance: HIGH

- As Found: Recurrent

- ID: M1730

- Name: Nasopharyngeal Carcinoma

- Relevance: HIGH

- As Found: Nasopharyngeal Carcinoma

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M12254

- Name: Nasopharyngeal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M13517

- Name: Pharyngeal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12962

- Name: Otorhinolaryngologic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M9348

- Name: Head and Neck Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12253

- Name: Nasopharyngeal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13515

- Name: Pharyngeal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12961

- Name: Otorhinolaryngologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4047

- Name: Nasopharyngeal Carcinoma

- Relevance: HIGH

- As Found: Nasopharyngeal Carcinoma

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000077274

- Term: Nasopharyngeal Carcinoma

- ID: D000012008

- Term: Recurrence

### Intervention Browse Module - Ancestors

- ID: D000000964

- Term: Antimetabolites, Antineoplastic

- ID: D000000963

- Term: Antimetabolites

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- 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: M2985

- Name: Gemcitabine

- Relevance: HIGH

- As Found: Activity

- ID: M2853

- Name: Immunomodulating Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4281

- Name: Antimetabolites

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000093542

- Term: Gemcitabine

### Misc Info Module

- Version Holder: 2024-05-24
