The Clinical Efficacy and Safety of Intratumoral Injection of Chemotherapy for Advanced Solid Tumors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorWuxi People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Intratumoral Injection of Chemotherapy
Procedure/SurgeryThis 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Intratumoral Injection of ChemotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Relief degree of tumors
It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST1.1）
Time frame
through study completion, an average of 5 yearSecondary outcomes
1
Progress free survival（PFS）
The duration from the beginning of treatment to cancer recurrence or progression
Time frame
3 years, year 32
Overall survival（OS）
The duration from the beginning of treatment to patient death
Time frame
5 years, year 5Sponsors and contacts
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Source ClinicalTrials.gov