## Protocol Section
### Identification Module
**NCT ID:** NCT06413017

**Brief Title:** Nimotuzumab Combined With ICIs for the Treatment of Advanced Liver Cancer After First Line Treatment Failure

**Official Title:** Nimotuzumab Combined With Immune Checkpoint Inhibitors for the Treatment of Advanced Liver Cancer After First Line Treatment Failure ，a Prospective， Open Label，Single Arm，Phase II Trail

#### Organization Study ID Info
**ID:** Nim-PC-7
#### Organization
**Class:** OTHER
**Full Name:** Tianjin Medical University Cancer Institute and Hospital
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-07-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-08-31

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Tianjin Medical University Cancer Institute and Hospital

#### Responsible Party

**Investigator Affiliation:** Tianjin Medical University Cancer Institute and Hospital

**Investigator Full Name:** Jihui Hao

**Investigator Title:** Chief physician

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This is a phase II, open-label, single-arm clinical study of nimotuzumab in combination with immune checkpoint inhibitors in patients with advanced liver cancer who have failed first-line therapy

**Detailed Description:** This study is a prospective, single-arm study, and plans to include 30 patients with hepatocellular carcinoma who do not respond to first-line therapy with a protoPD-1 (or PD-L1) inhibitor in combination with nimotuzumab in the posterior line, and receive nimotuzumab 400mg, D1, QW in combination with PD-1 (or PD-L1) inhibitor in the later line of treatment until disease progression and intolerable toxicity

### Conditions Module

**Conditions:**

- HCC

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients will be treated with nimotuzumab combined immune checkpoint inhibitors treatment

**Intervention Names:**

- Drug: Nimotuzumab

- Drug: ICIs(Immune checkpoint inhibitors)

**Label:** Nimtuzumab combined ICIs

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Nimtuzumab combined ICIs

**Description:** Nimtuzumab：400mg,i.v.,once a week,until tumor progression、Death or untalerable toxicity

**Name:** Nimotuzumab

**Other Names:**

- h-R3

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Nimtuzumab combined ICIs

**Description:** Use it as it is describe in the instructions from the specification

**Name:** ICIs(Immune checkpoint inhibitors)

**Other Names:**

- PD-1 or PD-L1

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** （Objtective reseponse rate）

**Measure:** ORR（Objtective reseponse rate）

**Time Frame:** up to 24 month

#### Secondary Outcomes

**Description:** Time from the first dose to death

**Measure:** OS（overall survival）

**Time Frame:** up to 24 month

**Description:** time form fist dose to tumor progression or death

**Measure:** PFS（pregression free survival）

**Time Frame:** up to 24 month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subjects with histologically or cytologically confirmed advanced hepatocellular carcinoma (HCC), or The clinical diagnosis meets the American Association of Liver Diseases (AASLD) diagnostic criteria for hepatocellular carcinoma；
* Prior experience of targeted, immune, progression after conventional therapy, or intolerance (including TKIs,ICIs, chemotherapy, VEGF monoclonal antibody, or ICIs in combination with TKIs/VEGFs monoclonal antibody/chemotherapy)；
* Child-Pugh liver function rating within 7 days prior to the first dose of study drug: Grade A or better grade B (≤ 7 points) ;
* Phase B or C as assessed by BCLC; or Phase III as assessed by CNLC;
* Within 4 weeks prior to the first dose, at least one measurable target lesion remained according to mRECIST v1.1；
* EGFR postive and RAS wildtype；

Exclusion Criteria:

* Dignosised as hepatic cholangiocarcinoma, mixed cell carcinoma, or fibrolamellar cell carcinoma；
* History of hepatic encephalopathy within 6 months prior to the first dose of this study；
* Portal hypertension with endoscopic red signs, or those who are considered by the investigator to be at high risk of bleeding or who have had esophageal or gastric variceal bleeding within 6 months prior to the first dose；
* Symptomatic brain or meningeal metastases (unless patient is treated\> 3 months, no evidence of progression on imaging within 4 weeks prior to treatment, and tumor-related clinical symptoms is stable)

**Maximum Age:** 79 Years

**Minimum Age:** 17 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** gaochuntao@tjmuch.com

**Name:** Chuntao Gao, Dr

**Phone:** 022-2340123

**Phone Ext:** 022-2340123

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tianjin

**Contacts:**

***Contact 1:***

- **Email:** gaochuntao@tjmuch.com

- **Name:** Chuntao Gao, MD

- **Phone:** 022-2340123

- **Phone Ext:** 3077

- **Role:** CONTACT

**Country:** China

**Facility:** Tianjin Medical University Cancer Institute and Hospital

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Tianjin Medical University Cancer Institute and Hospital

**Name:** Jihui Hao, Dr

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000008107

- Term: Liver Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M11113

- Name: Liver Neoplasms

- Relevance: HIGH

- As Found: Liver Cancer

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System 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: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008113

- Term: Liver Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Hemat

- Name: Hematinics

### Intervention Browse Module - Browse Leaves

- ID: M2342

- Name: Immune Checkpoint Inhibitors

- Relevance: HIGH

- As Found: Remitting

- ID: M288889

- Name: Nimotuzumab

- Relevance: HIGH

- As Found: Details

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000501466

- Term: Nimotuzumab

- ID: D000082082

- Term: Immune Checkpoint Inhibitors

### Misc Info Module

- Version Holder: 2024-05-31
