CHG0521 Oral Coating in Patients with Solid Tissue Tumor/Recurrent/Metastatic TSCC

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGuangzhou University of Traditional Chinese Medicine

About this trial

This is a prospective single-arm loading test study of CHG0521 oral coating in patients with solid tissue tumor/recurrent/metastatic TSCC

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Age range: 18-80 years, encompassing both males and females. 2. Confirmation of tongue squamous cell carcinoma through histopathology or cytology is required.

Disqualifiers

1. Patients with tongue squamous cell carcinoma who have undergone tumor resection without any residual tumor; 2. Patients with a known allergy to any therapeutic ingredient or a history of hypersensitivity or allergic constitution; 3. Patients who have experienced a severe infection within 4 weeks prior to the first use of the investigational drug, and whose common adverse reaction criteria were graded as >2; 4. Patients with a history of immune deficiency, organ transplantation, or allogeneic bone marrow transplantation; 5. Patients currently enrolled in another concurrent clinical study; 6. Pregnant and lactating women.

Trial design

Design model

Single group

Treatments tested in this trial

  • CHG0521 Oral Coating

    Drug

    The subjects will receive an oral coating of CHG0521 in the form of drops, in addition to the clinician\'s standard treatment regimen, for a duration of 6 months or until confirmed progression, unacceptable toxicity, or any criteria for withdrawal from the trial.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Drug: CHG0521 Oral CoatingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: at least 30% decrease in the sum of diameters of target lesions) per RECIST 1.1.

Time frame
24 weeks

Secondary outcomes

1

QOL

Washington Quality of Life Score

Time frame
24 weeks
2

PCR

Pathologic Complete Response

Time frame
24 weeks
3

DRR

Disease Recurrence Rate

Time frame
24 weeks
4

OS

Overall Survival

Time frame
1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: