Head and Neck Squamous Cell CarcinomaNCT06686342
PDO Based Drug Sensitive Test in R/M HNSCC
An observational study of Head and Neck Squamous Cell Carcinoma and Patient Derived Organoid, run by Huashan Hospital at 2 sites in China.
Trial summary
To evaluate the consistency of drug efficacy between the clinical systemic treatment and drug sensitive test based on patient-derived organoid in R/M HNSCC patients, using a prospective and multicenter observational study to increase the generalizability and reliability of research conclusion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Patient Derived Organoid, Drug Sensitive Test in Vitro
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 26 Mar 2025to 11 Nov 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is an observational study, according to previous literature reports combined with the actual clinical situation of institution/collaborating institutions, a total of 100 participants are planned to be included.
Who may be able to join
- Pathologically confirmed R/M HNSCC patients
- Tumor tissues available for organoid culture
- ECOG score: 0-2 points
- Life expectancy > 3 months
- Normal major organ function, tolerable to chemotherapy, targeted therapy, immunotherapy: a. Hematology examination criteria must meet: WBC≥4.0×109/L, ANC≥1.5×109/L, PLT≥80×109/L, Hb≥90 g/L (no blood transfusion or blood products within 14 days, no use of G-CSF or other hematopoietic growth factors); b. Biochemical examination must meet the following criteria: serum albumin≥3.0 g/dL (30 g/L), TBIL≤1.5×ULN, ALT, AST≤2.5×ULN, BUN and CRE≤1.5×ULN or endogenous creatinine clearance≥60 ml/min (Cockcroft-Gault formula); c. Good coagulation function: defined as International Normalized Ratio (INR) or Prothrombin Time (PT)≤1.5 times ULN; if the study participant is on anticoagulant therapy, as long as PT is within the intended range of the anticoagulant medication
- Able to understand the content of informed consent form, sign the informed consent form, and willing to cooperate with the follow-up
Who cannot join
- Metastatic tumors in the head and neck region, or non-HNSCC such as sarcoma, adenocarcinoma, nasopharyngeal carcinoma, etc.
- Known allergy to the study drugs or their active ingredients or any excipients; or had a severe allergic reaction to other monoclonal antibodies
- Pregnant or breastfeeding female patients; or women of childbearing age with positive pregnancy test results (serum or urine) within 7 days before enrollment, or negative results but refusing to use effective contraception during the study period and 2 months after the last administration of study medication; or male patients with partners of childbearing age, refusing to use effective contraception during the study period and 2 months after the last administration of study medication
- Severe liver diseases (such as cirrhosis), kidney diseases, respiratory system diseases, hematopoietic system diseases, or endocrine system diseases, uncontrolled diseases
- Infected with HIV, active hepatitis B (HBV-DNA≥104 copies/ml) or hepatitis C (hepatitis C antibody positive, and HCR-RNA above the lower limit of detection of the analytical method), uncontrolled diseases
- Within 6 months before enrollment, the following conditions occurred: myocardial infarction, severe/unstable angina, NYHA class 2 or above heart failure, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure, uncontrolled diseases
Show all 9Show fewer
- Patients with mental illness or known history of psychiatric drug abuse or drug addiction
- Unable to give consent, unable to obtain the required amount of tumor tissue for the study
- Other serious physical or mental diseases or laboratory test abnormalities that may increase the risk of participating in the study or interfere with the study results; or any other situation that the researchers deem unsuitable for participation in this study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 1 recruiting
- Active, not recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
- Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Lai-ping Zhong, MD, PhD, +862152888915, zhonglp@hotmail.com
Tong-chao Zhao, MD, PhD, +862152889999 ext. 7182, 961497591@qq.com
About this study
Official title: Consistency Evaluation of Drug Efficacy Between Clinical Systemic Treatment and Drug Sensitive Test Based on Patient-derived Organoid in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: A Prospective, Multicenter, Observational Study
To evaluate the consistency of drug efficacy between the clinical systemic treatment and drug sensitive test based on patient-derived organoid in R/M HNSCC patients, using a prospective and multicenter observational study to increase the generalizability and reliability of research conclusion.
Read the detailed description
Head and neck squamous cell carcinoma (HNSCC) is one of the most common cancers threatening human health, recurrent and metastatic HNSCC (R/M HNSCC) is the most difficult to treat, and the prognosis is very poor. Drug treatment is the mostly choice; however, individualized treatment needs to determine the specific treatment plan according to the characteristics of the patient and the tumor. In addition to NGS sequencing, high-throughput models for in vitro drug sensitive tests are an effective means to improve clinical efficacy.
Organoids are in vitro cultured micro-organs with 3D structures, capable of spontaneous self-renewal, self-organization, and differentiation to form complex structures similar to real tissues, partially simulating the physiological functions of the source tissue or organ. Compared with other in vitro and in vivo models such as cell lines and patient-derived xenograft models, organoid models have unique advantages: they can more vividly retain the phenotypic, genetic, and functional characteristics of the original tissue, and have a short modeling cycle, high cost-performance ratio, and can achieve high throughput drug sensitive test. In 2018, a study showed that ex vivo drug sensitivity testing based on gastrointestinal tumor organoids has a very high predictive value for clinical efficacy, with a sensitivity of 100%, specificity of 93%, and positive and negative predictive values of 88% and 100%, respectively. In addition, cancer organoids have been developed from many other cancer types and its feasibility in guiding precision medicine is investigated. The aim of present study is to evaluate the consistency of drug efficacy between the clinical systemic treatment and drug sensitive test based on patient-derived organoid in R/M HNSCC patients. A prospective and multicenter observational study is planned to increase the generalizability and reliability of research conclusion.
The patients with R/M HNSCC would receive drug treatment according to the clinical guideline or doctor's experience, at the same time, tumor biopsy samples would be collected to establish PDO for drug sensitive test. Fifteen different drug regimens sensitive test would be performed, including the actual drug regimens that the patients clinically receive, and the corresponding ex vivo tumor inhibition rate would be recorded. After the patients received the clinical treatment, they would be followed up to collect the objective response rate (ORR), disease control rate (DCR), progression-free survival time (PFS), and overall survival time (OS). Finally, the consistency of drug efficacy would be evaluated between clinical systemic treatment and drug sensitive test based on patient-derived organoid.
- Conditions
- Head and Neck Squamous Cell Carcinoma, Patient Derived Organoid, Drug Sensitive Test in Vitro
- Being tested
- No intervention, No Intervention: Observational Cohort
- Keywords
- Recurrent/metastatic head and neck squamous cell carcinoma, Patient-derived organoid, Drug sensitive test in vitro
- Medical subject headings
- 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.
No interventionOther
The patients with R/M HNSCC would receive drug treatment according to the clinical guideline or doctor's experience, at the same time, tumor biopsy samples would be collected to establish PDO for drug sensitive test. But no intervention would be used based on the PDO drug sensitive test.
No Intervention: Observational CohortOther
The patients with R/M HNSCC would receive drug treatment according to the clinical guideline or doctor's experience, at the same time, tumor biopsy samples would be collected to establish PDO for drug sensitive test. But no intervention would be used based on the PDO drug sensitive test.
| Study group | Role | What they receive |
|---|---|---|
| Observational cohort | The observational group of patients with R/M HNSCC would receive drug treatment according to the clinical guideline or doctor's experience. No intervention would be provided based on the drug sensitive test from patient-derived organoid. Receives: Other: No intervention; Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
The proportion of patients whose tumor size is reduced to a pre-specified value and maintained for a minimum required duration, which is the sum of the proportions of Complete Response (CR) and Partial Response (PR).
Measured: 2 years
Disease Control Rate
The proportion of patients whose tumor size is reduced or stable and maintained for a minimum required duration, which is the sum of the proportions of Complete Response (CR), Partial Response (PR), and Stable Disease (SD).
Measured: 2 years
Secondary outcomes (4)
The success rate of establishment and drug sensite test on PDO
Number of successful organoid construction and completion of drug sensitive test/Total number of participants ×100%.
Measured: 2 years
Tumor Growth Inhibition of PDO
(1-T/C) × 100%, where T is the survival rate of PDO drug treatment group, and C is the survival rate of PDO control group.
Measured: 2 weeks
Overall Survival
The time from enrollment of participants to death (for any reason).
Measured: 2 years
Progression-Free Survival
The time from enrollment of participants to occurrence of tumor progression (in any aspect) or death (for any reason).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start26 Mar 2025
- Primary completion11 Nov 2026 (estimated)
- Study completion11 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Head and Neck 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Cancer Hospital, China, Eye & ENT Hospital of Fudan University, Dongfang Hospital Affiliated to Tongji University, Shandong Cancer Hospital and Institute, Qilu Hospital of Shandong University, Shandong Provincial Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Tongji Hospital, Hospital of Stomatology, Wuhan University, Second Affiliated Hospital, Zhejiang University, School of Medicine, First Affiliated Hospital of Zhejiang University, Sir Run Run Shaw Hospital, Zhejiang Cancer Hospital, Shanghai Zhongshan Hospital, Shanghai Huangpu District Central Hospital
- Responsible party
- Principal investigator, Lai-ping Zhong, Huashan Hospital
- Investigators
- Lai-ping Zhong, MD, PhD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686342
- Sponsor's protocol ID
- DST-PDO-HNSCC
- Status last verified
- Aug 2025
- First submitted
- 11 Nov 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the completion of the study.
Publications
Pasch CA, Favreau PF, Yueh AE, Babiarz CP, Gillette AA, Sharick JT, Karim MR, Nickel KP, DeZeeuw AK, Sprackling CM, Emmerich PB, DeStefanis RA, Pitera RT, Payne SN, Korkos DP, Clipson L, Walsh CM, Miller D, Carchman EH, Burkard ME, Lemmon KK, Matkowskyj KA, Newton MA, Ong IM, Bassetti MF, Kimple RJ, Skala MC, Deming DA. Patient-Derived Cancer Organoid Cultures to Predict Sensitivity to Chemotherapy and Radiation. Clin Cancer Res. 2019 Sep 1;25(17):5376-5387. doi: 10.1158/1078-0432.CCR-18-3590. Epub 2019 Jun 7.
PubMed 31175091Vlachogiannis G, Hedayat S, Vatsiou A, Jamin Y, Fernandez-Mateos J, Khan K, Lampis A, Eason K, Huntingford I, Burke R, Rata M, Koh DM, Tunariu N, Collins D, Hulkki-Wilson S, Ragulan C, Spiteri I, Moorcraft SY, Chau I, Rao S, Watkins D, Fotiadis N, Bali M, Darvish-Damavandi M, Lote H, Eltahir Z, Smyth EC, Begum R, Clarke PA, Hahne JC, Dowsett M, de Bono J, Workman P, Sadanandam A, Fassan M, Sansom OJ, Eccles S, Starling N, Braconi C, Sottoriva A, Robinson SP, Cunningham D, Valeri N. Patient-derived organoids model treatment response of metastatic gastrointestinal cancers. Science. 2018 Feb 23;359(6378):920-926. doi: 10.1126/science.aao2774.
PubMed 29472484
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consistency Evaluation of Drug Efficacy Between Clinical Systemic Treatment and Drug Sensitive Test Based on Patient-derived Organoid in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: A Prospective, Multicenter, Observational Study
- ClinicalTrials.gov ID
- NCT06686342
- Acronym / sponsor ID
- DST-PDO-HNSCC
- Conditions
- Head and Neck Squamous Cell Carcinoma, Patient Derived Organoid, Drug Sensitive Test in Vitro
- Keywords
- Recurrent/metastatic head and neck squamous cell carcinoma, Patient-derived organoid, Drug sensitive test in vitro
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Shanghai Cancer Hospital, China, Eye & ENT Hospital of Fudan University, Dongfang Hospital Affiliated to Tongji University, Shandong Cancer Hospital and Institute, Qilu Hospital of Shandong University, Shandong Provincial Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Tongji Hospital, Hospital of Stomatology, Wuhan University, Second Affiliated Hospital, Zhejiang University, School of Medicine, First Affiliated Hospital of Zhejiang University, Sir Run Run Shaw Hospital, Zhejiang Cancer Hospital, Shanghai Zhongshan Hospital, Shanghai Huangpu District Central Hospital
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 11 Nov 2026 (estimated)
- Study completion
- 11 Nov 2028 (estimated)
- First posted
- 13 Nov 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.
To evaluate the consistency of drug efficacy between the clinical systemic treatment and drug sensitive test based on patient-derived organoid in R/M HNSCC patients, using a prospective and multicenter observational study to increase the generalizability and reliability of research conclusion.
Detailed description
Head and neck squamous cell carcinoma (HNSCC) is one of the most common cancers threatening human health, recurrent and metastatic HNSCC (R/M HNSCC) is the most difficult to treat, and the prognosis is very poor. Drug treatment is the mostly choice; however, individualized treatment needs to determine the specific treatment plan according to the characteristics of the patient and the tumor. In addition to NGS sequencing, high-throughput models for in vitro drug sensitive tests are an effective means to improve clinical efficacy.
Organoids are in vitro cultured micro-organs with 3D structures, capable of spontaneous self-renewal, self-organization, and differentiation to form complex structures similar to real tissues, partially simulating the physiological functions of the source tissue or organ. Compared with other in vitro and in vivo models such as cell lines and patient-derived xenograft models, organoid models have unique advantages: they can more vividly retain the phenotypic, genetic, and functional characteristics of the original tissue, and have a short modeling cycle, high cost-performance ratio, and can achieve high throughput drug sensitive test. In 2018, a study showed that ex vivo drug sensitivity testing based on gastrointestinal tumor organoids has a very high predictive value for clinical efficacy, with a sensitivity of 100%, specificity of 93%, and positive and negative predictive values of 88% and 100%, respectively. In addition, cancer organoids have been developed from many other cancer types and its feasibility in guiding precision medicine is investigated. The aim of present study is to evaluate the consistency of drug efficacy between the clinical systemic treatment and drug sensitive test based on patient-derived organoid in R/M HNSCC patients. A prospective and multicenter observational study is planned to increase the generalizability and reliability of research conclusion.
The patients with R/M HNSCC would receive drug treatment according to the clinical guideline or doctor's experience, at the same time, tumor biopsy samples would be collected to establish PDO for drug sensitive test. Fifteen different drug regimens sensitive test would be performed, including the actual drug regimens that the patients clinically receive, and the corresponding ex vivo tumor inhibition rate would be recorded. After the patients received the clinical treatment, they would be followed up to collect the objective response rate (ORR), disease control rate (DCR), progression-free survival time (PFS), and overall survival time (OS). Finally, the consistency of drug efficacy would be evaluated between clinical systemic treatment and drug sensitive test based on patient-derived organoid.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational cohort | – | Other: No intervention, Other: No Intervention: Observational CohortThe observational group of patients with R/M HNSCC would receive drug treatment according to the clinical guideline or doctor's experience. No intervention would be provided based on the drug sensitive test from patient-derived organoid. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is an observational study, according to previous literature reports combined with the actual clinical situation of institution/collaborating institutions, a total of 100 participants are planned to be included.
Key inclusion criteria (6 listed)
- Pathologically confirmed R/M HNSCC patients
- Tumor tissues available for organoid culture
- ECOG score: 0-2 points
- Life expectancy > 3 months
- Normal major organ function, tolerable to chemotherapy, targeted therapy, immunotherapy: a. Hematology examination criteria must meet: WBC≥4.0×109/L, ANC≥1.5×109/L, PLT≥80×109/L, Hb≥90 g/L (no blood transfusion or blood products within 14 days, no use of G-CSF or other hematopoietic growth factors); b. Biochemical examination must meet the following criteria: serum albumin≥3.0 g/dL (30 g/L), TBIL≤1.5×ULN, ALT, AST≤2.5×ULN, BUN and CRE≤1.5×ULN or endogenous creatinine clearance≥60 ml/min (Cockcroft-Gault formula); c. Good coagulation function: defined as International Normalized Ratio (INR) or Prothrombin Time (PT)≤1.5 times ULN; if the study participant is on anticoagulant therapy, as long as PT is within the intended range of the anticoagulant medication
Key exclusion criteria (9 listed)
- Metastatic tumors in the head and neck region, or non-HNSCC such as sarcoma, adenocarcinoma, nasopharyngeal carcinoma, etc.
- Known allergy to the study drugs or their active ingredients or any excipients; or had a severe allergic reaction to other monoclonal antibodies
- Pregnant or breastfeeding female patients; or women of childbearing age with positive pregnancy test results (serum or urine) within 7 days before enrollment, or negative results but refusing to use effective contraception during the study period and 2 months after the last administration of study medication; or male patients with partners of childbearing age, refusing to use effective contraception during the study period and 2 months after the last administration of study medication
- Severe liver diseases (such as cirrhosis), kidney diseases, respiratory system diseases, hematopoietic system diseases, or endocrine system diseases, uncontrolled diseases
- Infected with HIV, active hepatitis B (HBV-DNA≥104 copies/ml) or hepatitis C (hepatitis C antibody positive, and HCR-RNA above the lower limit of detection of the analytical method), uncontrolled diseases
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 |
|---|---|---|
| No interventionThe patients with R/M HNSCC would receive drug treatment according to the clinical guideline or doctor's experience, at the same time, tumor biopsy samples would be collected to establish PDO for drug sensitive test. But no intervention would be used based on the PDO drug sensitive test. | Other | Observational cohort |
| No Intervention: Observational CohortThe patients with R/M HNSCC would receive drug treatment according to the clinical guideline or doctor's experience, at the same time, tumor biopsy samples would be collected to establish PDO for drug sensitive test. But no intervention would be used based on the PDO drug sensitive test. | Other | Observational cohort |
Primary outcome
Objective Response Rate
Time frame: 2 years
The proportion of patients whose tumor size is reduced to a pre-specified value and maintained for a minimum required duration, which is the sum of the proportions of Complete Response (CR) and Partial Response (PR).
Disease Control Rate
Time frame: 2 years
The proportion of patients whose tumor size is reduced or stable and maintained for a minimum required duration, which is the sum of the proportions of Complete Response (CR), Partial Response (PR), and Stable Disease (SD).
4 secondary outcomes
The success rate of establishment and drug sensite test on PDO
Time frame: 2 years
Tumor Growth Inhibition of PDO
Time frame: 2 weeks
Overall Survival
Time frame: 2 years
Progression-Free Survival
Time frame: 2 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 3 Sep 2025.
- Results publication: PubMed 31175091Pasch CA, Favreau PF, Yueh AE, Babiarz CP, Gillette AA, Sharick JT, Karim MR, Nickel KP, DeZeeuw AK, Sprackling CM, Emmerich PB, DeStefanis RA, Pitera RT, Payne SN, Korkos DP, Clipson L, Walsh CM, Miller D, Carchman EH, Burkard ME, Lemmon KK, Matkowskyj KA, Newton MA, Ong IM, Bassetti MF, Kimple RJ, Skala MC, Deming DA. Patient-Derived Cancer Organoid Cultures to Predict Sensitivity to Chemotherapy and Radiation. Clin Cancer Res. 2019 Sep 1;25(17):5376-5387. doi: 10.1158/1078-0432.CCR-18-3590. Epub 2019 Jun 7.
- Results publication: PubMed 29472484Vlachogiannis G, Hedayat S, Vatsiou A, Jamin Y, Fernandez-Mateos J, Khan K, Lampis A, Eason K, Huntingford I, Burke R, Rata M, Koh DM, Tunariu N, Collins D, Hulkki-Wilson S, Ragulan C, Spiteri I, Moorcraft SY, Chau I, Rao S, Watkins D, Fotiadis N, Bali M, Darvish-Damavandi M, Lote H, Eltahir Z, Smyth EC, Begum R, Clarke PA, Hahne JC, Dowsett M, de Bono J, Workman P, Sadanandam A, Fassan M, Sansom OJ, Eccles S, Starling N, Braconi C, Sottoriva A, Robinson SP, Cunningham D, Valeri N. Patient-derived organoids model treatment response of metastatic gastrointestinal cancers. Science. 2018 Feb 23;359(6378):920-926. doi: 10.1126/science.aao2774.
- Individual participant dataSharing planned: Yes. After the completion of the study.
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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.
Lai-ping Zhong, MD, PhD principal investigator
Huashan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Squamous Cell Carcinoma and Patient Derived Organoid, run by Huashan Hospital at 2 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 6 inclusion and 9 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 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Lai-ping Zhong, MD, PhD (+862152888915, zhonglp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 2 years). 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?
On the ClinicalTrials.gov record for NCT06686342, which also lists 2 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 3 Sep 2025; AzTrials last refreshed its copy on 28 Oct 2026.