The Clinical Efficacy and Safety of Intratumoral Injection of Chemotherapy for Advanced Solid Tumors

NCT06430515 | Recruiting

• 1 other identifier: KY23197
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Intratumoral Injection; Cancer

Outcome Measures

Primary Outcomes (1)

• Relief degree of tumors

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

  through study completion, an average of 5 year

Secondary Outcomes (2)

• Progress free survival（PFS）

  3 years, year 3

• Overall survival（OS）

  5 years, year 5

Study Arms (1)

Intratumoral Injection of Chemotherapy

EXPERIMENTAL

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.

Procedure: Intratumoral Injection of Chemotherapy

Interventions

Intratumoral Injection of Chemotherapy PROCEDURE

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.

Intratumoral Injection of Chemotherapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18-75 years;
• 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;
• 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);
• ECOG score of 0-2, lifespan \> 12 weeks;
• 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;
• Voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.

You may not qualify if:

• The patient is diagnosed with central nervous system leukemia(symptoms, signs, imaging, cerebrospinal fluid);
• White blood cell count ≥ 50×10\^9/ L or patients with rapid disease progression can't be guaranteed to complete a full treatment cycle;
• Patients with fungal, bacterial, viral or other uncontrollable infections or requiring four-level isolation treatment.
• HIV, HBV and HCV positive;
• Patients with diseases of the central nervous system or autoimmune central nervous system lesions, Including stroke, epilepsy, dementia;
• 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;
• Patients are on anticoagulation or have severe coagulopathy (APTT\>70);
• Patients in any condition requiring systemic treatment with corticosteroids or other immunosuppressive agents within 2weeks prior to investigational drug administration;
• 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;
• Subjects in other conditions that are considered unsuitable for this study by the investigator.

Sponsors & Collaborators

• Wuxi People's Hospital: lead

Study Sites (1)

Wuxi People's Hospital

Wuxi, Jiangsu, 214043, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Peihua Lu

CONTACT

13621500031; lphty1_1@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

CN (1)