Radiotherapy, AdjuvantNCT07657169
Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast
A study testing Postoperative Radiotherapy (PORT) in people with Radiotherapy, Adjuvant and Phyllodes Breast Tumor, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 4 sites in China.
Trial summary
Phyllodes tumor (PT) of the breast is a rare fibroepithelial neoplasm, and the role of postoperative radiotherapy (PORT) remains controversial. Our team has previously established a molecular subtyping system for PT, classifying patients into four subtypes. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Radiotherapy, Adjuvant, Phyllodes Breast Tumor, Prognosis
- What is being tested?
- Postoperative Radiotherapy (PORT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesChina
- Study dates
- 15 Oct 2026to 31 Dec 2030
- Phase
- Interventional
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥18 years and ≤75 years.
- Histologically confirmed breast phyllodes tumor (PT) by the central laboratory, with molecular classification as MN1 or MN2 subtype via transcriptome sequencing or IHC;
- Primary or ipsilateral local recurrence following R0 resection (negative margins) before enrollment;
- Pathologically confirmed borderline or malignant PT;
- No evidence of distant metastasis (M0);
- ECOG performance status 0-1;
- Signed informed consent before treatment;
- Expected randomization and study entry within 8-12 weeks (no later than 16 weeks) after surgery.
Who cannot join
- Previous radiation to the same-side breast or chest;
- women, or those of childbearing potential refusing effective contraception; Pregnancy, lactation, or refusal of contraception by fertile subjects;
- Grade III-IV bone marrow suppression: WBC≤1.9*109/L，ANC≤0.9*109/L，PLT≤49*109/L，AST, ALT≥2*ULN;
- Significant diarrhea, severe active infection, uncontrolled systemic disease, interstitial lung disease, active connective tissue disease, or LVEF < 50%;
- Significant diarrhea, severe active infection, uncontrolled systemic disease, interstitial lung disease, active connective tissue disease, or LVEF < 50%;
- Prior or planned systemic anti-tumor therapy (chemotherapy, targeted therapy, immunotherapy, or investigational agents) during the study;
- Participation in other clinical trials that precludes study inclusion;
- Any other condition that, in the opinion of the investigator, renders the patient unsuitable for the trial.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510120
Yan Nie, +86 020-81332587, nieyan7@mail.sysu.edu.cn
The Second Hospital of Shandong University
Jinan, Shandong, 250033
Fei Wang, +86 17660083882, fei.wang@sdu.edu.cn
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
Haibo Wang, +86 18661805787, hbwang66@qdu.edu.cn
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518000
Junwei Cui, +86 13828832157
About this study
Official title: Efficacy and Safety of Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast: A Prospective, Open-Label, Randomized Controlled Trial
Phyllodes tumor (PT) of the breast is a rare fibroepithelial neoplasm, and the role of postoperative radiotherapy (PORT) remains controversial. Our team has previously established a molecular subtyping system for PT, classifying patients into four subtypes. Among them, the malignant novel 1/2 (MN1/MN2) subtypes exhibit extremely high risk of local recurrence, and retrospective data suggest that PORT may significantly improve local control in these subtypes. This study aims to evaluate the efficacy and safety of molecular subtype-guided postoperative radiotherapy (PORT) in patients with MN-subtype phyllodes tumor of the breast. This prospective, multicenter, open-label, randomized controlled trial plans to enroll 160 patients with molecularly confirmed MN1 or MN2 subtype who have undergone R0 resection. Patients will be randomized in a 1:1 ratio to either the PORT group or the observation-only group, with stratification by negative margin width (<1 cm vs. ≥1 cm) and molecular subtype (MN1 vs. MN2). The primary endpoint is 2-year local recurrence-free survival (LRFS). Secondary endpoints include distant metastasis-free survival (DMFS), disease-free survival (DFS), overall survival (OS), and the incidence of acute and late radiotherapy-related toxicities. By using an innovative molecular subtyping system to precisely select the target population, this study seeks to assess the benefit and safety of PORT in MN-subtype phyllodes tumors. The results are expected to provide the highest level of evidence for this specific subgroup, advance treatment strategies toward "molecular subtype-guided precision radiotherapy," improve patient outcomes, and inform future clinical guidelines.
- Being tested
- Postoperative Radiotherapy (PORT)
- Medical subject headings
- Phyllodes Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative Radiotherapy (PORT)Radiation
Radiotherapy delivered after R0 resection. For breast-conserving surgery: whole-breast irradiation (50 Gy in 25 fractions, 2 Gy/fraction, 5 fractions/week) followed by sequential tumor bed boost (10-16 Gy in 5-8 fractions, 2 Gy/fraction). For mastectomy: chest wall irradiation (50 Gy in 25 fractions). Techniques allowed: IMRT, VMAT, or TOMO. No routine regional nodal irradiation unless pathologically confirmed nodal involvement. Target volume and organ-at-risk constraints as per protocol (e.g., ipsilateral lung Dmean <15 Gy, heart Dmean <5 Gy for left-sided tumors). Acute and late toxicities assessed by CTCAE v5.0.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative Radiotherapy (PORT) | Experimental | Patients receive postoperative radiotherapy starting within 8-12 weeks (max 16 weeks) after R0 resection. For breast-conserving surgery: whole-breast irradiation (50 Gy/25 fractions) plus sequential tumor bed boost (10-16 Gy/5-8 fractions). For mastectomy: chest wall irradiation (50 Gy/25 fractions). No routine regional nodal irradiation unless pathologically positive. Acute and late toxicities monitored per CTCAE v5.0. Receives: Radiation: Postoperative Radiotherapy (PORT) |
| Observation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Local Recurrence-Free Survival (LRFS)
Time from randomization to the first documented locoregional recurrence (ipsilateral breast/chest wall or regional lymph nodes) confirmed by imaging and/or pathology, or death from any cause, whichever occurs first. Patients alive without locoregional recurrence are censored at the date of last known follow-up.
Measured: From randomization up to 2 years post-randomization (primary analysis at 2 years)
Secondary outcomes (4)
Distant Metastasis-Free Survival (DMFS)
Measured: From randomization up to 5 years (primary analysis for secondary endpoints will be performed at 2 years, with extended follow-up up to 5 years)
Disease-Free Survival (DFS)
Measured: From randomization up to 5 years (primary analysis of secondary endpoints at 2 years, with extended follow-up to 5 years)
Overall Survival (OS)
Measured: From randomization up to 5 years
Incidence of Acute and Late Radiotherapy-Related Toxicities
Proportion of patients experiencing adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Acute toxicity is defined as events occurring within 90 days after start of radiotherapy; late toxicity as events occurring >90 days after start of radiotherapy. Includes radiation dermatitis, radiation pneumonitis, cardiac toxicity, rib fracture, breast/chest wall fibrosis, and secondary malignancies.
Measured: From start of radiotherapy up to 5 years post-randomization (acute: within 90 days; late: from 90 days to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Radiotherapy, AdjuvantStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Nie, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657169
- Sponsor's protocol ID
- SYSKY-2026-390-02
- Status last verified
- May 2026
- First submitted
- 15 Jun 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zheng WH, Long ZQ, Kou J, Sun JY, Li FY, Zhang LL, He ZY. Postoperative radiation therapy in localized breast malignant phyllodes tumors: RPA-derived risk model identifies high-benefit subgroups with local control improvement. Breast. 2025 Dec;84:104617. doi: 10.1016/j.breast.2025.104617. Epub 2025 Oct 22.
PubMed 41135329Kim YJ, Kim K. Radiation therapy for malignant phyllodes tumor of the breast: An analysis of SEER data. Breast. 2017 Apr;32:26-32. doi: 10.1016/j.breast.2016.12.006. Epub 2016 Dec 22.
PubMed 28013032Ma B, Li X, Zhuang Z, Han M, Zhang Y, Ye F, Bi Z, Deng W, Zhang J, Yang Y, Nie Y. Effects of radiotherapy in borderline and malignant phyllodes tumors after R0 resection: a propensity score analysis. Ther Adv Med Oncol. 2025 Oct 27;17:17588359251387556. doi: 10.1177/17588359251387556. eCollection 2025.
PubMed 41179117Varghese SS, Sasidharan B, Manipadam MT, Paul MJ, Backianathan S. Radiotherapy in Phyllodes Tumour. J Clin Diagn Res. 2017 Jan;11(1):XC01-XC03. doi: 10.7860/JCDR/2017/24591.9167. Epub 2017 Jan 1.
PubMed 28274029Zhao W, Tian Q, Zhao A, Wang B, Yang J, Wang L, Zhang L, Dong D, Chen L, Yang J. The role of adjuvant radiotherapy in patients with malignant phyllodes tumor of the breast: a propensity-score matching analysis. Breast Cancer. 2021 Jan;28(1):110-118. doi: 10.1007/s12282-020-01135-7. Epub 2020 Aug 3.
PubMed 32748225Barth RJ Jr, Wells WA, Mitchell SE, Cole BF. A prospective, multi-institutional study of adjuvant radiotherapy after resection of malignant phyllodes tumors. Ann Surg Oncol. 2009 Aug;16(8):2288-94. doi: 10.1245/s10434-009-0489-2. Epub 2009 May 8.
PubMed 19424757Donato AR, Goncalves R, Maesaka JY, Aguiar FN, Soares JM Jr, Ruiz CA, Filassi JR, Baracat EC. Phyllodes tumors of the breast: A comprehensive review of diagnosis, treatment, and follow-up. Clinics (Sao Paulo). 2025 Mar 14;80:100617. doi: 10.1016/j.clinsp.2025.100617. eCollection 2025.
PubMed 40088524Zhang H, Tang S, Biskup E, Zhang Y, Yong L, Chen L, Cai F. Long-term Survival After Diverse Therapeutic Modalities in Malignant Phyllodes Tumors of the Breast. Technol Cancer Res Treat. 2022 Jan-Dec;21:15330338221121086. doi: 10.1177/15330338221121086.
PubMed 36000314Gradishar WJ, Moran MS, Abraham J, Abramson V, Aft R, Agnese D, Allison KH, Anderson B, Bailey J, Burstein HJ, Chen N, Chew H, Dang C, Elias AD, Giordano SH, Goetz MP, Jankowitz RC, Javid SH, Krishnamurthy J, Leitch AM, Lyons J, McCloskey S, McShane M, Mortimer J, Patel SA, Rosenberger LH, Rugo HS, Santa-Maria C, Schneider BP, Smith ML, Soliman H, Stringer-Reasor EM, Telli ML, Wei M, Wisinski KB, Yeung KT, Young JS, Schonfeld R, Kumar R. Breast Cancer, Version 3.2024, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2024 Jul;22(5):331-357. doi: 10.6004/jnccn.2024.0035.
PubMed 39019058
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast: A Prospective, Open-Label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07657169
- Acronym / sponsor ID
- SYSKY-2026-390-02
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 18 Jun 2026 (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.
Phyllodes tumor (PT) of the breast is a rare fibroepithelial neoplasm, and the role of postoperative radiotherapy (PORT) remains controversial. Our team has previously established a molecular subtyping system for PT, classifying patients into four subtypes. Among them, the malignant novel 1/2 (MN1/MN2) subtypes exhibit extremely high risk of local recurrence, and retrospective data suggest that PORT may significantly improve local control in these subtypes. This study aims to evaluate the efficacy and safety of molecular subtype-guided postoperative radiotherapy (PORT) in patients with MN-subtype phyllodes tumor of the breast. This prospective, multicenter, open-label, randomized controlled trial plans to enroll 160 patients with molecularly confirmed MN1 or MN2 subtype who have undergone R0 resection. Patients will be randomized in a 1:1 ratio to either the PORT group or the observation-only group, with stratification by negative margin width (<1 cm vs. ≥1 cm) and molecular subtype (MN1 vs. MN2). The primary endpoint is 2-year local recurrence-free survival (LRFS). Secondary endpoints include distant metastasis-free survival (DMFS), disease-free survival (DFS), overall survival (OS), and the incidence of acute and late radiotherapy-related toxicities. By using an innovative molecular subtyping system to precisely select the target population, this study seeks to assess the benefit and safety of PORT in MN-subtype phyllodes tumors. The results are expected to provide the highest level of evidence for this specific subgroup, advance treatment strategies toward "molecular subtype-guided precision radiotherapy," improve patient outcomes, and inform future clinical guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative Radiotherapy (PORT) | Experimental | Radiation: Postoperative Radiotherapy (PORT)Patients receive postoperative radiotherapy starting within 8-12 weeks (max 16 weeks) after R0 resection. For breast-conserving surgery: whole-breast irradiation (50 Gy/25 fractions) plus sequential tumor bed boost (10-16 Gy/5-8 fractions). For mastectomy: chest wall irradiation (50 Gy/25 fractions). No routine regional nodal irradiation unless pathologically positive. Acute and late toxicities monitored per CTCAE v5.0. |
| Observation | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female patients aged ≥18 years and ≤75 years.
- Histologically confirmed breast phyllodes tumor (PT) by the central laboratory, with molecular classification as MN1 or MN2 subtype via transcriptome sequencing or IHC;
- Primary or ipsilateral local recurrence following R0 resection (negative margins) before enrollment;
- Pathologically confirmed borderline or malignant PT;
- No evidence of distant metastasis (M0);
Key exclusion criteria (8 listed)
- Previous radiation to the same-side breast or chest;
- women, or those of childbearing potential refusing effective contraception; Pregnancy, lactation, or refusal of contraception by fertile subjects;
- Grade III-IV bone marrow suppression: WBC≤1.9*109/L，ANC≤0.9*109/L，PLT≤49*109/L，AST, ALT≥2*ULN;
- Significant diarrhea, severe active infection, uncontrolled systemic disease, interstitial lung disease, active connective tissue disease, or LVEF < 50%;
- Significant diarrhea, severe active infection, uncontrolled systemic disease, interstitial lung disease, active connective tissue disease, or LVEF < 50%;
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 |
|---|---|---|
| Postoperative Radiotherapy (PORT)Radiotherapy delivered after R0 resection. For breast-conserving surgery: whole-breast irradiation (50 Gy in 25 fractions, 2 Gy/fraction, 5 fractions/week) followed by sequential tumor bed boost (10-16 Gy in 5-8 fractions, 2 Gy/fraction). For mastectomy: chest wall irradiation (50 Gy in 25 fractions). Techniques allowed: IMRT, VMAT, or TOMO. No routine regional nodal irradiation unless pathologically confirmed nodal involvement. Target volume and organ-at-risk constraints as per protocol (e.g., ipsilateral lung Dmean <15 Gy, heart Dmean <5 Gy for left-sided tumors). Acute and late toxicities assessed by CTCAE v5.0. | Radiation | Postoperative Radiotherapy (PORT) |
Primary outcome
2-year Local Recurrence-Free Survival (LRFS)
Time frame: From randomization up to 2 years post-randomization (primary analysis at 2 years)
Time from randomization to the first documented locoregional recurrence (ipsilateral breast/chest wall or regional lymph nodes) confirmed by imaging and/or pathology, or death from any cause, whichever occurs first. Patients alive without locoregional recurrence are censored at the date of last known follow-up.
4 secondary outcomes
Distant Metastasis-Free Survival (DMFS)
Time frame: From randomization up to 5 years (primary analysis for secondary endpoints will be performed at 2 years, with extended follow-up up to 5 years)
Disease-Free Survival (DFS)
Time frame: From randomization up to 5 years (primary analysis of secondary endpoints at 2 years, with extended follow-up to 5 years)
Overall Survival (OS)
Time frame: From randomization up to 5 years
Incidence of Acute and Late Radiotherapy-Related Toxicities
Time frame: From start of radiotherapy up to 5 years post-randomization (acute: within 90 days; late: from 90 days to 5 years)
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 5 Nov 2026.
- Background: PubMed 41135329Zheng WH, Long ZQ, Kou J, Sun JY, Li FY, Zhang LL, He ZY. Postoperative radiation therapy in localized breast malignant phyllodes tumors: RPA-derived risk model identifies high-benefit subgroups with local control improvement. Breast. 2025 Dec;84:104617. doi: 10.1016/j.breast.2025.104617. Epub 2025 Oct 22.
- Background: PubMed 28013032Kim YJ, Kim K. Radiation therapy for malignant phyllodes tumor of the breast: An analysis of SEER data. Breast. 2017 Apr;32:26-32. doi: 10.1016/j.breast.2016.12.006. Epub 2016 Dec 22.
- Background: PubMed 41179117Ma B, Li X, Zhuang Z, Han M, Zhang Y, Ye F, Bi Z, Deng W, Zhang J, Yang Y, Nie Y. Effects of radiotherapy in borderline and malignant phyllodes tumors after R0 resection: a propensity score analysis. Ther Adv Med Oncol. 2025 Oct 27;17:17588359251387556. doi: 10.1177/17588359251387556. eCollection 2025.
- Background: PubMed 28274029Varghese SS, Sasidharan B, Manipadam MT, Paul MJ, Backianathan S. Radiotherapy in Phyllodes Tumour. J Clin Diagn Res. 2017 Jan;11(1):XC01-XC03. doi: 10.7860/JCDR/2017/24591.9167. Epub 2017 Jan 1.
- Background: PubMed 32748225Zhao W, Tian Q, Zhao A, Wang B, Yang J, Wang L, Zhang L, Dong D, Chen L, Yang J. The role of adjuvant radiotherapy in patients with malignant phyllodes tumor of the breast: a propensity-score matching analysis. Breast Cancer. 2021 Jan;28(1):110-118. doi: 10.1007/s12282-020-01135-7. Epub 2020 Aug 3.
- Background: PubMed 19424757Barth RJ Jr, Wells WA, Mitchell SE, Cole BF. A prospective, multi-institutional study of adjuvant radiotherapy after resection of malignant phyllodes tumors. Ann Surg Oncol. 2009 Aug;16(8):2288-94. doi: 10.1245/s10434-009-0489-2. Epub 2009 May 8.
- Background: PubMed 40088524Donato AR, Goncalves R, Maesaka JY, Aguiar FN, Soares JM Jr, Ruiz CA, Filassi JR, Baracat EC. Phyllodes tumors of the breast: A comprehensive review of diagnosis, treatment, and follow-up. Clinics (Sao Paulo). 2025 Mar 14;80:100617. doi: 10.1016/j.clinsp.2025.100617. eCollection 2025.
- Background: PubMed 36000314Zhang H, Tang S, Biskup E, Zhang Y, Yong L, Chen L, Cai F. Long-term Survival After Diverse Therapeutic Modalities in Malignant Phyllodes Tumors of the Breast. Technol Cancer Res Treat. 2022 Jan-Dec;21:15330338221121086. doi: 10.1177/15330338221121086.
- Background: PubMed 39019058Gradishar WJ, Moran MS, Abraham J, Abramson V, Aft R, Agnese D, Allison KH, Anderson B, Bailey J, Burstein HJ, Chen N, Chew H, Dang C, Elias AD, Giordano SH, Goetz MP, Jankowitz RC, Javid SH, Krishnamurthy J, Leitch AM, Lyons J, McCloskey S, McShane M, Mortimer J, Patel SA, Rosenberger LH, Rugo HS, Santa-Maria C, Schneider BP, Smith ML, Soliman H, Stringer-Reasor EM, Telli ML, Wei M, Wisinski KB, Yeung KT, Young JS, Schonfeld R, Kumar R. Breast Cancer, Version 3.2024, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2024 Jul;22(5):331-357. doi: 10.6004/jnccn.2024.0035.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative Radiotherapy (PORT) in people with Radiotherapy, Adjuvant and Phyllodes Breast Tumor, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 4 sites 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 8 inclusion and 8 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
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 Yan Nie (+86 020-81332587, nieyan7@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Local Recurrence-Free Survival (LRFS) (time frame: From randomization up to 2 years post-randomization (primary analysis at 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07657169, which also lists 9 linked publications.
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 5 Nov 2026.