## Protocol Section
### Identification Module
**NCT ID:** NCT06430515

**Brief Title:** The Clinical Efficacy and Safety of Intratumoral Injection of Chemotherapy for Advanced Solid Tumors

**Official Title:** The Clinical Efficacy and Safety of Intratumoral Injection of Chemotherapy for Advanced Solid Tumors Through Fine Needle Puncture

#### Organization Study ID Info
**ID:** KY23197
#### Organization
**Class:** OTHER
**Full Name:** Wuxi People's Hospital
### Status Module
#### Completion Date
**Date:** 2028-12-31

**Type:** ESTIMATED

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

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-09-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Wuxi People's Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This project intends to investigate the clinical efficacy of intra-tumoural injection of chemotherapeutic agents (e.g. cisplatin, oxaliplatin, etc.)via fine needle aspiration guided by CT or ultrasound in patients with advanced solid cancers to validate the safety and efficacy.

**Detailed Description:** Malignant solid tumours including lung and liver cancers are the most common malignant tumours worldwide and have a very high mortality rate. Currently,the clinical practice mainly relies on systemic administration of chemotherapeutic agents usually by intravenous infusion for patients with solid cancer with multiple metastases,but the overall efficiency is not high.Single or multiple chemotherapeutic agents are infused intratumourally to increase the local drug concentration in the tumour, improve efficacy and reduce drug resistance and systemic adverse effects. This project intends to investigate the clinical efficacy of intra-tumoural injection of chemotherapeutic agents (e.g. cisplatin, oxaliplatin, etc.)via fine needle aspiration guided by CT or ultrasound in patients with advanced solid cancers to validate the safety and efficacy.

### Conditions Module

**Conditions:**

- Intratumoral Injection

- Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Fine-needle puncture guided by CT or ultrasound and infusion of chemotherapeutic agents (e.g. cisplatin, oxaliplatin, etc.) via the tumour increases the local drug concentration in the tumour, improves therapeutic efficacy and reduces drug resistance and systemic adverse effects.

**Intervention Names:**

- Procedure: Intratumoral Injection of Chemotherapy

**Label:** Intratumoral Injection of Chemotherapy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intratumoral Injection of Chemotherapy

**Description:** This project intends to investigate the clinical efficacy of intra-tumoural injection of chemotherapeutic agents (e.g. cisplatin, oxaliplatin, etc.)via fine needle aspiration guided by CT or ultrasound in patients with advanced solid cancers to validate the safety and efficacy.

**Name:** Intratumoral Injection of Chemotherapy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST1.1）

**Measure:** Relief degree of tumors

**Time Frame:** through study completion, an average of 5 year

#### Secondary Outcomes

**Description:** The duration from the beginning of treatment to cancer recurrence or progression

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

**Time Frame:** 3 years, year 3

**Description:** The duration from the beginning of treatment to patient death

**Measure:** Overall survival（OS）

**Time Frame:** 5 years, year 5

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Male or female aged 18-75 years;
2. Subjects must have histologically- or cytologically-confirmed diagnosis of advanced solid tumor(s) and have progressed on or is not eligible for available standard therapy;
3. Subjects have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, or nodal lesions with short diameter ≥ 15 mm);
4. ECOG score of 0-2, lifespan \> 12 weeks;
5. Women of childbearing age who have a negative pregnancy test within 7 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method during study treatment and within at least 6 months after the last dose of investigational drug;
6. Voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.

Exclusion Criteria:

1. The patient is diagnosed with central nervous system leukemia(symptoms, signs, imaging, cerebrospinal fluid);
2. White blood cell count ≥ 50×10\^9/ L or patients with rapid disease progression can't be guaranteed to complete a full treatment cycle;
3. Patients with fungal, bacterial, viral or other uncontrollable infections or requiring four-level isolation treatment.
4. HIV, HBV and HCV positive;
5. Patients with diseases of the central nervous system or autoimmune central nervous system lesions, Including stroke, epilepsy, dementia;
6. Patients have myocardial infection, cardiac angiography or stents, active angina or other obvious clinical symptoms, or have cardiopathic asthma or cardiovascular lymphocytic infiltrates，within 12 months;
7. Patients are on anticoagulation or have severe coagulopathy (APTT\>70);
8. Patients in any condition requiring systemic treatment with corticosteroids or other immunosuppressive agents within 2weeks prior to investigational drug administration;
9. Subjects having any serious uncontrolled disease or in other conditions that would preclude them from receiving study treatment and are considered unsuitable for this study in the opinion of the investigator;
10. Subjects in other conditions that are considered unsuitable for this study by the investigator.

**Maximum Age:** 85 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** lphty1_1@njmu.edu.cn

**Name:** Peihua Lu

**Phone:** 13621500031

**Phone Ext:** +86

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Wuxi

**Contacts:**

***Contact 1:***

- **Email:** 13625653@qq.com

- **Name:** Peihua Lu, MD

- **Phone:** 13621500031

- **Role:** CONTACT

**Country:** China

**Facility:** Wuxi People's Hospital

**State:** Jiangsu

**Status:** RECRUITING

**Zip:** 214043

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M6182

- Name: Cisplatin

- Relevance: LOW

- As Found: Unknown

- ID: M1674

- Name: Oxaliplatin

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
