Breast CancerHFIBRNCT06830083
Hypofractionated Radiation Fractionation in Breast Cancer Patients With Implant-Based Reconstruction
A study testing Hypofractionated Radiation Therapy and Conventional fraction radiotherapy in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
It is a randomized trial to assess the safety and efficacy between hypofractionation radiation and conventional radiation in women who have undergone mastectomy and immediate breast reconstruction. The investigators will evaluate reconstruction complication, radiotherapy side effects, cosmetic and oncologic outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Hypofractionated Radiation Therapy and Conventional fraction radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2025to Dec 2033
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Pathological diagnosis of stage I-III breast cancer (non-T4), >18 years old; 2. Complete breast cancer resection (including skin-sparing and nipple-sparing total resection) 3. According to the guidelines of the Chinese Anticancer Society, postoperative adjuvant radiotherapy is required; 4. Undergo immediate reconstructive surgery (tissue dilator or permanent implant)
Who cannot join
- Auto-reconstruction surgery
- Clinical or pathological T4
- Both sides need radiotherapy
- Have a history of chest radiotherapy
- Pregnancy/lactation
- Participate in other drug clinical trials
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, 1 recruiting
- Recruiting
Jiangsu Province People's Hospital/The First Affiliated with Nanjing Medical University
Nanjing, Jiangsu, 210029
Xinchen, 86-025-68307676, ziria9@126.com
About this study
It is a randomized trial to assess the safety and efficacy between hypofractionation radiation and conventional radiation in women who have undergone mastectomy and immediate breast reconstruction. The investigators will evaluate reconstruction complication, radiotherapy side effects, cosmetic and oncologic outcomes.
Read the detailed description
Patients with breast cancer frequently have requirement for breast reconstruction after mastectomy. For patients with limited autologous tissue availability, implant-based reconstruction remains an effective alternative. Due to the absence of high-level evidence, collaborative efforts between surgical and radiation oncology teams are advised to determine the optimal sequencing and techniques for integrating reconstruction surgery with radiotherapy. The ongoing Alliance A221505 and FABREC phase III randomized controlled trials are comparing the incidence of reconstructive complications following hypofractionated and conventional fractionation radiotherapy. FABREC trial recently showed the hypofractionated regimen did not significantly improve change in physical well-being（PWB), domain of the Functional Assessment of Cancer Therapy-Breast (FACT-B) quality-of-life assessment tool, compared with the conventional fractionation radiotherapy. This trial added to the increasing experience with HF PMRT in patients with implant-based reconstruction.
In 2019, the European Society for Radiotherapy and Oncology (ESTRO) provided guidelines for target delineation based on the position of the implant in breast reconstruction to minimize the irradiation of normal tissues. Existing studies on the risk of complications from irradiating expanders and implants have yielded inconsistent conclusions, with each approach having its own advantages and disadvantages.
Our study aims to compare the incidence of reconstructive complications between hypofractionated and conventional fractionation radiotherapy after implant-based reconstruction surgery to provide high-level evidence for medium-dose hypofractionated radiotherapy after immediate implant-based reconstructive surgery.
- Conditions
- Breast Cancer
- Being tested
- Hypofractionated Radiation Therapy, Conventional fraction radiotherapy
- Keywords
- implant-based reconstruction surgery, hypofraction radiation therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Radiation TherapyRadiation
Also called HF
Hypofractionation regimen: Total dose to the chest wall and the regional lymph nodes is 4050 cGy, and each fraction consists of 270 cGy per day(daily, Monday through Friday )
Conventional fraction radiotherapyRadiation
Also called CF
Total dose of plan tumor volume is 5000 cGy，and each fraction will consist of 200 cGy per day. 25 fractions(daily, Monday through Friday) to the chest wall and to the supraclavicular (with or without axillary) lymph nodes.
| Study group | Role | What they receive |
|---|---|---|
| conventional fraction radiotherapy | Active comparator | Total dose of plan tumor volume is 5000 cGy，and each fraction will consist of 200 cGy per day. 25 fractions(daily, Monday through Friday) to the chest wall and to the regional (with or without axillary) lymph nodes. Receives: Radiation: Conventional fraction radiotherapy |
| hypofractioned radiotherapy | Experimental | Total dose of plan tumor volume is 4050 cGy，and each fraction will consist of 270 cGy per day. 15 fractions(daily, Monday through Friday) to the chest wall and to the regional (with or without axillary) lymph nodes. Receives: Radiation: Hypofractionated Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major complication
implant related complications requiring reoperation such as severe necrosis，severe infections, severe capsular contracture, implant rupture and implant exposure.
Measured: From enrollment to the end of treatment at 24 months
Secondary outcomes (4)
Any breast-related complications
Complications included infections, wound dehiscence, skin flap necrosis, implant exposure, capsular contracture, seroma, and hematoma.
Measured: From enrollment to the end of treatment at 24 months
Absolute reconstruction failure
Measured: From enrollment to the end of treatment at 24 months
Oncologic outcomes
local-regional recurrence free survival
Measured: From enrollment to the end of treatment at 5 years
Cosmetic outcomes
satisfaction with breast and physical and psychosocial well-bing after radiotherapy will be assessed from baseline to 24 months by trained physicians using Breast-Q Version 2.0© Reconstruction Module Scales Chinese (CN) Version .
Measured: From enrollment to the end of treatment at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start30 Jan 2025
- Primary completion30 Dec 2030 (estimated)
- Study completionDec 2033 (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 Breast CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- 840 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Taizhou People's Hospital, Hunan Cancer Hospital
- Responsible party
- Principal investigator, Sun Xinchen, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830083
- Sponsor's protocol ID
- First Affiliated Hospital, Nan
- Acronym
- HFIBR
- Status last verified
- Jan 2025
- First submitted
- 26 Jan 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mutter RW, Giri S, Fruth BF, Remmes NB, Boughey JC, Harless CA, Ruddy KJ, McGee LA, Afzal A, Gao RW, Shumway DA, Vern-Gross TZ, Villarraga HR, Kenison SL, Kang Y, Wong WW, Stish BJ, Merrell KW, Yan ES, Park SS, Corbin KS, Vargas CE. Conventional versus hypofractionated postmastectomy proton radiotherapy in the USA (MC1631): a randomised phase 2 trial. Lancet Oncol. 2023 Oct;24(10):1083-1093. doi: 10.1016/S1470-2045(23)00388-1. Epub 2023 Sep 8.
PubMed 37696281Wong JS, Uno H, Tramontano AC, Fisher L, Pellegrini CV, Abel GA, Burstein HJ, Chun YS, King TA, Schrag D, Winer E, Bellon JR, Cheney MD, Hardenbergh P, Ho A, Horst KC, Kim JN, Leonard KL, Moran MS, Park CC, Recht A, Soto DE, Shiloh RY, Stinson SF, Snyder KM, Taghian AG, Warren LE, Wright JL, Punglia RS. Hypofractionated vs Conventionally Fractionated Postmastectomy Radiation After Implant-Based Reconstruction: A Randomized Clinical Trial. JAMA Oncol. 2024 Oct 1;10(10):1370-1378. doi: 10.1001/jamaoncol.2024.2652.
PubMed 39115975Wang SL, Fang H, Song YW, Wang WH, Hu C, Liu YP, Jin J, Liu XF, Yu ZH, Ren H, Li N, Lu NN, Tang Y, Tang Y, Qi SN, Sun GY, Peng R, Li S, Chen B, Yang Y, Li YX. Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with high-risk breast cancer: a randomised, non-inferiority, open-label, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):352-360. doi: 10.1016/S1470-2045(18)30813-1. Epub 2019 Jan 30.
PubMed 30711522Salvestrini V, Valzano M, Meattini I, Becherini C, Visani L, Francolini G, Morelli I, Bertini N, Orzalesi L, Bernini M, Bianchi S, Simontacchi G, Livi L, Desideri I. Anatomical assessment of local recurrence site in breast cancer patients after breast reconstruction and post-mastectomy radiotherapy: implications for radiation volumes and techniques. Radiol Med. 2024 Jun;129(6):845-854. doi: 10.1007/s11547-024-01812-z. Epub 2024 Apr 11.
PubMed 38602657Wu ZY, Han HH, Kim HJ, Lee J, Chung IY, Kim J, Lee S, Han J, Eom JS, Kim SB, Gong G, Kim HH, Son BH, Ahn SH, Ko B. Locoregional recurrence following nipple-sparing mastectomy with immediate breast reconstruction: Patterns and prognostic significance. Eur J Surg Oncol. 2021 Jun;47(6):1309-1315. doi: 10.1016/j.ejso.2021.01.006. Epub 2021 Jan 13.
PubMed 33495030Kaidar-Person O, Vrou Offersen B, Hol S, Arenas M, Aristei C, Bourgier C, Cardoso MJ, Chua B, Coles CE, Engberg Damsgaard T, Gabrys D, Jagsi R, Jimenez R, Kirby AM, Kirkove C, Kirova Y, Kouloulias V, Marinko T, Meattini I, Mjaaland I, Nader Marta G, Witt Nystrom P, Senkus E, Skytta T, Tvedskov TF, Verhoeven K, Poortmans P. ESTRO ACROP consensus guideline for target volume delineation in the setting of postmastectomy radiation therapy after implant-based immediate reconstruction for early stage breast cancer. Radiother Oncol. 2019 Aug;137:159-166. doi: 10.1016/j.radonc.2019.04.010. Epub 2019 May 17.
PubMed 31108277Kim YH, Yang YJ, Lee DW, Song SY, Lew DH, Yang EJ. Prevention of Postoperative Complications by Prepectoral versus Subpectoral Breast Reconstruction: A Systematic Review and Meta-Analysis. Plast Reconstr Surg. 2024 Jan 1;153(1):10e-24e. doi: 10.1097/PRS.0000000000010493. Epub 2023 Apr 4.
PubMed 37010460Zhang X, Ning S, Zhang Y. Complications After Prepectoral Versus Subpectoral Breast Reconstruction in Patients Receiving Postmastectomy Radiation Therapy: A Systematic Review and Meta-Analysis. Aesthetic Plast Surg. 2024 Nov;48(21):4421-4429. doi: 10.1007/s00266-024-04096-w. Epub 2024 May 3.
PubMed 38700543Jagsi R, Momoh AO, Qi J, Hamill JB, Billig J, Kim HM, Pusic AL, Wilkins EG. Impact of Radiotherapy on Complications and Patient-Reported Outcomes After Breast Reconstruction. J Natl Cancer Inst. 2018 Feb 1;110(2):157-65. doi: 10.1093/jnci/djx148.
PubMed 28954300
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated Radiation Fractionation in Breast Cancer Patients With Implant-Based Reconstruction
- ClinicalTrials.gov ID
- NCT06830083
- Acronym / sponsor ID
- HFIBR / First Affiliated Hospital, Nan
- Conditions
- Breast Cancer
- Keywords
- implant-based reconstruction surgery, hypofraction radiation therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Taizhou People's Hospital, Hunan Cancer Hospital
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 17 Feb 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.
It is a randomized trial to assess the safety and efficacy between hypofractionation radiation and conventional radiation in women who have undergone mastectomy and immediate breast reconstruction. The investigators will evaluate reconstruction complication, radiotherapy side effects, cosmetic and oncologic outcomes.
Detailed description
Patients with breast cancer frequently have requirement for breast reconstruction after mastectomy. For patients with limited autologous tissue availability, implant-based reconstruction remains an effective alternative. Due to the absence of high-level evidence, collaborative efforts between surgical and radiation oncology teams are advised to determine the optimal sequencing and techniques for integrating reconstruction surgery with radiotherapy. The ongoing Alliance A221505 and FABREC phase III randomized controlled trials are comparing the incidence of reconstructive complications following hypofractionated and conventional fractionation radiotherapy. FABREC trial recently showed the hypofractionated regimen did not significantly improve change in physical well-being（PWB), domain of the Functional Assessment of Cancer Therapy-Breast (FACT-B) quality-of-life assessment tool, compared with the conventional fractionation radiotherapy. This trial added to the increasing experience with HF PMRT in patients with implant-based reconstruction.
In 2019, the European Society for Radiotherapy and Oncology (ESTRO) provided guidelines for target delineation based on the position of the implant in breast reconstruction to minimize the irradiation of normal tissues. Existing studies on the risk of complications from irradiating expanders and implants have yielded inconsistent conclusions, with each approach having its own advantages and disadvantages.
Our study aims to compare the incidence of reconstructive complications between hypofractionated and conventional fractionation radiotherapy after implant-based reconstruction surgery to provide high-level evidence for medium-dose hypofractionated radiotherapy after immediate implant-based reconstructive surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional fraction radiotherapy | Active comparator | Radiation: Conventional fraction radiotherapyTotal dose of plan tumor volume is 5000 cGy，and each fraction will consist of 200 cGy per day. 25 fractions(daily, Monday through Friday) to the chest wall and to the regional (with or without axillary) lymph nodes. |
| hypofractioned radiotherapy | Experimental | Radiation: Hypofractionated Radiation TherapyTotal dose of plan tumor volume is 4050 cGy，and each fraction will consist of 270 cGy per day. 15 fractions(daily, Monday through Friday) to the chest wall and to the regional (with or without axillary) lymph nodes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Pathological diagnosis of stage I-III breast cancer (non-T4), >18 years old; 2. Complete breast cancer resection (including skin-sparing and nipple-sparing total resection) 3. According to the guidelines of the Chinese Anticancer Society, postoperative adjuvant radiotherapy is required; 4. Undergo immediate reconstructive surgery (tissue dilator or permanent implant)
Key exclusion criteria (6 listed)
- Auto-reconstruction surgery
- Clinical or pathological T4
- Both sides need radiotherapy
- Have a history of chest radiotherapy
- Pregnancy/lactation
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 |
|---|---|---|
| Hypofractionated Radiation TherapyAlso: HFHypofractionation regimen: Total dose to the chest wall and the regional lymph nodes is 4050 cGy, and each fraction consists of 270 cGy per day(daily, Monday through Friday ) | Radiation | hypofractioned radiotherapy |
| Conventional fraction radiotherapyAlso: CFTotal dose of plan tumor volume is 5000 cGy，and each fraction will consist of 200 cGy per day. 25 fractions(daily, Monday through Friday) to the chest wall and to the supraclavicular (with or without axillary) lymph nodes. | Radiation | conventional fraction radiotherapy |
Primary outcome
Major complication
Time frame: From enrollment to the end of treatment at 24 months
implant related complications requiring reoperation such as severe necrosis，severe infections, severe capsular contracture, implant rupture and implant exposure.
4 secondary outcomes
Any breast-related complications
Time frame: From enrollment to the end of treatment at 24 months
Absolute reconstruction failure
Time frame: From enrollment to the end of treatment at 24 months
Oncologic outcomes
Time frame: From enrollment to the end of treatment at 5 years
Cosmetic outcomes
Time frame: From enrollment to the end of treatment at 24 months
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 17 Feb 2025.
- Results publication: PubMed 37696281Mutter RW, Giri S, Fruth BF, Remmes NB, Boughey JC, Harless CA, Ruddy KJ, McGee LA, Afzal A, Gao RW, Shumway DA, Vern-Gross TZ, Villarraga HR, Kenison SL, Kang Y, Wong WW, Stish BJ, Merrell KW, Yan ES, Park SS, Corbin KS, Vargas CE. Conventional versus hypofractionated postmastectomy proton radiotherapy in the USA (MC1631): a randomised phase 2 trial. Lancet Oncol. 2023 Oct;24(10):1083-1093. doi: 10.1016/S1470-2045(23)00388-1. Epub 2023 Sep 8.
- Results publication: PubMed 39115975Wong JS, Uno H, Tramontano AC, Fisher L, Pellegrini CV, Abel GA, Burstein HJ, Chun YS, King TA, Schrag D, Winer E, Bellon JR, Cheney MD, Hardenbergh P, Ho A, Horst KC, Kim JN, Leonard KL, Moran MS, Park CC, Recht A, Soto DE, Shiloh RY, Stinson SF, Snyder KM, Taghian AG, Warren LE, Wright JL, Punglia RS. Hypofractionated vs Conventionally Fractionated Postmastectomy Radiation After Implant-Based Reconstruction: A Randomized Clinical Trial. JAMA Oncol. 2024 Oct 1;10(10):1370-1378. doi: 10.1001/jamaoncol.2024.2652.
- Results publication: PubMed 30711522Wang SL, Fang H, Song YW, Wang WH, Hu C, Liu YP, Jin J, Liu XF, Yu ZH, Ren H, Li N, Lu NN, Tang Y, Tang Y, Qi SN, Sun GY, Peng R, Li S, Chen B, Yang Y, Li YX. Hypofractionated versus conventional fractionated postmastectomy radiotherapy for patients with high-risk breast cancer: a randomised, non-inferiority, open-label, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):352-360. doi: 10.1016/S1470-2045(18)30813-1. Epub 2019 Jan 30.
- Results publication: PubMed 38602657Salvestrini V, Valzano M, Meattini I, Becherini C, Visani L, Francolini G, Morelli I, Bertini N, Orzalesi L, Bernini M, Bianchi S, Simontacchi G, Livi L, Desideri I. Anatomical assessment of local recurrence site in breast cancer patients after breast reconstruction and post-mastectomy radiotherapy: implications for radiation volumes and techniques. Radiol Med. 2024 Jun;129(6):845-854. doi: 10.1007/s11547-024-01812-z. Epub 2024 Apr 11.
- Results publication: PubMed 33495030Wu ZY, Han HH, Kim HJ, Lee J, Chung IY, Kim J, Lee S, Han J, Eom JS, Kim SB, Gong G, Kim HH, Son BH, Ahn SH, Ko B. Locoregional recurrence following nipple-sparing mastectomy with immediate breast reconstruction: Patterns and prognostic significance. Eur J Surg Oncol. 2021 Jun;47(6):1309-1315. doi: 10.1016/j.ejso.2021.01.006. Epub 2021 Jan 13.
- Results publication: PubMed 31108277Kaidar-Person O, Vrou Offersen B, Hol S, Arenas M, Aristei C, Bourgier C, Cardoso MJ, Chua B, Coles CE, Engberg Damsgaard T, Gabrys D, Jagsi R, Jimenez R, Kirby AM, Kirkove C, Kirova Y, Kouloulias V, Marinko T, Meattini I, Mjaaland I, Nader Marta G, Witt Nystrom P, Senkus E, Skytta T, Tvedskov TF, Verhoeven K, Poortmans P. ESTRO ACROP consensus guideline for target volume delineation in the setting of postmastectomy radiation therapy after implant-based immediate reconstruction for early stage breast cancer. Radiother Oncol. 2019 Aug;137:159-166. doi: 10.1016/j.radonc.2019.04.010. Epub 2019 May 17.
- Results publication: PubMed 37010460Kim YH, Yang YJ, Lee DW, Song SY, Lew DH, Yang EJ. Prevention of Postoperative Complications by Prepectoral versus Subpectoral Breast Reconstruction: A Systematic Review and Meta-Analysis. Plast Reconstr Surg. 2024 Jan 1;153(1):10e-24e. doi: 10.1097/PRS.0000000000010493. Epub 2023 Apr 4.
- Results publication: PubMed 38700543Zhang X, Ning S, Zhang Y. Complications After Prepectoral Versus Subpectoral Breast Reconstruction in Patients Receiving Postmastectomy Radiation Therapy: A Systematic Review and Meta-Analysis. Aesthetic Plast Surg. 2024 Nov;48(21):4421-4429. doi: 10.1007/s00266-024-04096-w. Epub 2024 May 3.
- Results publication: PubMed 28954300Jagsi R, Momoh AO, Qi J, Hamill JB, Billig J, Kim HM, Pusic AL, Wilkins EG. Impact of Radiotherapy on Complications and Patient-Reported Outcomes After Breast Reconstruction. J Natl Cancer Inst. 2018 Feb 1;110(2):157-65. doi: 10.1093/jnci/djx148.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Radiation Therapy and Conventional fraction radiotherapy in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University 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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 17 Feb 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.
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 Jiangsu Province People's Hospital (86-025-68307676, 13770662828@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major complication (time frame: From enrollment to the end of treatment at 24 months). 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 NCT06830083, 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 17 Feb 2025.