Head and Neck Squamous Cell Carcinoma; Underwent Surgery Within 6 Weeks and Postoperative Assessment Indicated High-risk FactorsPhase 3NCT06772428
Nano-crystalline Megestrol Acetate for Adjuvant Treatment in High-risk Head and Neck Squamous Cell Carcinoma After Surgery.
A Phase 3 study testing Nano-crystalline Megestrol Acetate Oral Suspension and standard treatment in people with Head and Neck Squamous Cell Carcinoma; Underwent Surgery Within 6 Weeks and Postoperative Assessment Indicated High-risk Factors, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study is a prospective, randomized, parallel-controlled clinical trial, with the primary objective to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone for adjuvant therapy in patients with high-risk squamous cell carcinoma… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma; Underwent Surgery Within 6 Weeks and Postoperative Assessment Indicated High-risk Factors
- What is being tested?
- Nano-crystalline Megestrol Acetate Oral Suspension and standard treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years at the time of enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Life expectancy ≥6 months.
- Patients with histologically or cytologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, and hypopharynx).
- Patients who have undergone surgery for head and neck squamous cell carcinoma within 6 weeks and are assessed postoperatively as having high-risk factors requiring radiotherapy ± chemotherapy.
Who cannot join
- Suffering from tumors in areas other than the oral cavity, oropharynx, larynx, and hypopharynx, such as nasopharyngeal carcinoma or other unknown primary head and neck tumors.
- Having any condition that affects gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrollable vomiting; currently undergoing tube feeding or parenteral nutrition.
- Suffering from anorexia due to neurosis, mental illness, or difficulty eating due to pain.
- Suffering from Acquired Immune Deficiency Syndrome (AIDS).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China School of Medicine/West China Hospital of Sichuan University
Chengdu, Sichuan, 610000
Qiongwen Zhang, 18683716951, qiongwen.zhang@scu.edu.cn
About this study
Official title: A Prospective, Randomized, Parallel-controlled Clinical Study of Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment Alone for Adjuvant Therapy in Patients With High-risk Factor Squamous Cell Carcinoma of the Head and Neck After Surgery.
This study is a prospective, randomized, parallel-controlled clinical trial, with the primary objective to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone for adjuvant therapy in patients with high-risk squamous cell carcinoma of the head and neck (excluding nasopharyngeal carcinoma) after surgery.
- Being tested
- Nano-crystalline Megestrol Acetate Oral Suspension, standard treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano-crystalline Megestrol Acetate Oral SuspensionDrug
Nano-crystalline Megestrol Acetate Oral Suspension, with a specification of 125 mg/mL, the study group takes 5 mL orally per day (625 mg/day), and continues medication; after completing the treatment cycle, patients who are assessed by the researchers as suitable for continued treatment may continue to receive therapy.
standard treatmentRadiation
radiotherapy ± chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy | Experimental | Not described Receives: Drug: Nano-crystalline Megestrol Acetate Oral Suspension; Radiation: standard treatment |
| Standard Therapy | Active comparator | Not described Receives: Radiation: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with improved appetite based on A/CS-12 assessment
Measured: Week 3
The proportion of subjects with a relative increase in body weight of >5% from baseline
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell Carcinoma; Underwent Surgery Within 6 Weeks and Postoperative Assessment Indicated High-risk FactorsStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772428
- Sponsor's protocol ID
- Megaxia ES-HNSCC-01
- Status last verified
- Dec 2024
- First submitted
- 25 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Parallel-controlled Clinical Study of Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment Alone for Adjuvant Therapy in Patients With High-risk Factor Squamous Cell Carcinoma of the Head and Neck After Surgery.
- ClinicalTrials.gov ID
- NCT06772428
- Acronym / sponsor ID
- Megaxia ES-HNSCC-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Jan 2025 (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 study is a prospective, randomized, parallel-controlled clinical trial, with the primary objective to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone for adjuvant therapy in patients with high-risk squamous cell carcinoma of the head and neck (excluding nasopharyngeal carcinoma) after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy | Experimental | Drug: Nano-crystalline Megestrol Acetate Oral Suspension, Radiation: standard treatment |
| Standard Therapy | Active comparator | Radiation: standard treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years at the time of enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Life expectancy ≥6 months.
- Patients with histologically or cytologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, larynx, and hypopharynx).
- Patients who have undergone surgery for head and neck squamous cell carcinoma within 6 weeks and are assessed postoperatively as having high-risk factors requiring radiotherapy ± chemotherapy.
Key exclusion criteria (4 listed)
- Suffering from tumors in areas other than the oral cavity, oropharynx, larynx, and hypopharynx, such as nasopharyngeal carcinoma or other unknown primary head and neck tumors.
- Having any condition that affects gastrointestinal absorption, such as dysphagia, malabsorption, or uncontrollable vomiting; currently undergoing tube feeding or parenteral nutrition.
- Suffering from anorexia due to neurosis, mental illness, or difficulty eating due to pain.
- Suffering from Acquired Immune Deficiency Syndrome (AIDS).
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 |
|---|---|---|
| Nano-crystalline Megestrol Acetate Oral SuspensionNano-crystalline Megestrol Acetate Oral Suspension, with a specification of 125 mg/mL, the study group takes 5 mL orally per day (625 mg/day), and continues medication; after completing the treatment cycle, patients who are assessed by the researchers as suitable for continued treatment may continue to receive therapy. | Drug | Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy |
| standard treatmentradiotherapy ± chemotherapy | Radiation | Nano-crystalline Megestrol Acetate Oral Suspension + Standard Therapy, Standard Therapy |
Primary outcome
The proportion of subjects with improved appetite based on A/CS-12 assessment
Time frame: Week 3
The proportion of subjects with a relative increase in body weight of >5% from baseline
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nano-crystalline Megestrol Acetate Oral Suspension and standard treatment in people with Head and Neck Squamous Cell Carcinoma; Underwent Surgery Within 6 Weeks and Postoperative Assessment Indicated High-risk Factors, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiongwen Zhang (18683716951, qiongwen.zhang@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects with improved appetite based on A/CS-12 assessment (time frame: Week 3). The study lists 2 primary outcomes in all. 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 13 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.