Squamous Cell CarcinomaNCT06609070
CHG0521 Oral Coating in Patients with Solid Tissue Tumor/Recurrent/Metastatic TSCC
A study testing CHG0521 Oral Coating in people with Squamous Cell Carcinoma and Squamous Cell Carcinoma of the Oral Cavity, run by Guangzhou University of Traditional Chinese Medicine.
Trial summary
This is a prospective single-arm loading test study of CHG0521 oral coating in patients with solid tissue tumor/recurrent/metastatic TSCC Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Oral Cavity
- What is being tested?
- CHG0521 Oral Coating
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age range: 18-80 years, encompassing both males and females. 2. Confirmation of tongue squamous cell carcinoma through histopathology or cytology is required.
- 3. Patients who are deemed unsuitable for surgery, have surgical indications but decline the treatment, or experience relapse and metastasis after surgery with no further surgical options available.
- 4. No concurrent use of other traditional Chinese medicine orally or externally within the past 3 months.
- 5. Presence of at least one measurable lesion according to RECIST 1.1 criteria. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- 7. Expected survival time should be equal to or greater than 3 months. 8. Liver function indicators: total bilirubin level ≤1.5 times the upper limit of normal (ULN), AST and ALT levels ≤2.5 times ULN (or ≤5 times ULN in case of liver metastasis).
- 9.Renal function indicators: serum creatinine (CRE) ≤1.5×ULN and calculated creatinine clearance (using Cockcroft-Gault formula) ≥60 ml/min.
- 10.The functionality of vital organs should be essentially normal.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: CHG0521 Oral Coating; TSCC
This is a prospective single-arm loading test study of CHG0521 oral coating in patients with solid tissue tumor/recurrent/metastatic TSCC
- Being tested
- CHG0521 Oral Coating
- Medical subject headings
- Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHG0521 Oral CoatingDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Drug: CHG0521 Oral Coating | Experimental | LSCC subjects who are not suitable for surgery after evaluation, or have surgical indications, do not agree to surgical treatment, or patients with recurrence and metastasis after surgery no longer have surgery. Receives: Drug: CHG0521 Oral Coating |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (5)
QOL
Washington Quality of Life Score
Measured: 24 weeks
PCR
Pathologic Complete Response
Measured: 24 weeks
DRR
Disease Recurrence Rate
Measured: 24 weeks
OS
Overall Survival
Measured: 1 year
AEs
Incidence and severity of adverse events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start15 Oct 2024 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jianwen guo, MD, Guangzhou University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609070
- Sponsor's protocol ID
- ZF2024-260-01
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHG0521 Oral Coating; TSCC
- ClinicalTrials.gov ID
- NCT06609070
- Acronym / sponsor ID
- ZF2024-260-01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective single-arm loading test study of CHG0521 oral coating in patients with solid tissue tumor/recurrent/metastatic TSCC
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug: CHG0521 Oral Coating | Experimental | Drug: CHG0521 Oral CoatingLSCC subjects who are not suitable for surgery after evaluation, or have surgical indications, do not agree to surgical treatment, or patients with recurrence and metastasis after surgery no longer have surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Age range: 18-80 years, encompassing both males and females. 2. Confirmation of tongue squamous cell carcinoma through histopathology or cytology is required.
- 3. Patients who are deemed unsuitable for surgery, have surgical indications but decline the treatment, or experience relapse and metastasis after surgery with no further surgical options available.
- 4. No concurrent use of other traditional Chinese medicine orally or externally within the past 3 months.
- 5. Presence of at least one measurable lesion according to RECIST 1.1 criteria. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- 7. Expected survival time should be equal to or greater than 3 months. 8. Liver function indicators: total bilirubin level ≤1.5 times the upper limit of normal (ULN), AST and ALT levels ≤2.5 times ULN (or ≤5 times ULN in case of liver metastasis).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHG0521 Oral CoatingThe 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. | Drug | Drug: CHG0521 Oral Coating |
Primary outcome
Objective Response Rate (ORR)
Time frame: 24 weeks
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.
5 secondary outcomes
QOL
Time frame: 24 weeks
PCR
Time frame: 24 weeks
DRR
Time frame: 24 weeks
OS
Time frame: 1 year
AEs
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing CHG0521 Oral Coating in people with Squamous Cell Carcinoma and Squamous Cell Carcinoma of the Oral Cavity, run by Guangzhou University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guo Jianwen (13724899379, jianwen_guo@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.