HPV-unrelated Head and Neck Squamous Cell CarcinomaPhase 2NCT07776340
Induction PD-1 Inhibitor and Chemotherapy Followed by Chemoradiotherapy in Unresectable or Inoperable HPV-negative LA-HNSCC
A Phase 2 study testing Tislelizumab, Paclitaxel and Cisplatin (75 mg/m2) in people with HPV-unrelated Head and Neck Squamous Cell Carcinoma, run by Fudan University at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate if adding chemotherapy and immunotherapy as induction treatment prior to definitive chemoradiotherapy could improve the outcomes of locally advanced HPV-negative head and neck squamous cell that are not amenable to surgery. The study aims to answer: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HPV-unrelated Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Tislelizumab, Paclitaxel and Cisplatin (75 mg/m2)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to Mar 2030
- Phase
- Phase 2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed HPV-negative head and neck squamous cell carcinoma (including laryngeal, hypopharyngeal, or oropharyngeal cancer).
- Loco-regionally advanced (Stage III-IVB) disease according to the 8th edition clinical staging system of the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC).
- Confirmed by a multidisciplinary team (MDT) as not amenable to curative surgery and deemed suitable for definitive concurrent chemoradiotherapy.
- "Not amenable to curative surgery" includes unresectable disease (anatomic impossibility of resection) or inoperable disease (patient medically unable to tolerate or declining surgical resection).
- ECOG performance status of 0-1.
- Pre-treatment neutrophils ≥ 1.5 × 10⁹/L, hemoglobin ≥ 90 g/L, platelets ≥ 100 × 10⁹/L; total bilirubin ≤ 1.5 × upper limit of normal (ULN), ALT ≤ 1.5 × ULN, AST ≤ 1.5 × ULN, ALP ≤ 2.5 × ULN; creatinine ≤ 1.5 × ULN.
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- Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN (patients on a stable dose of anticoagulant therapy, such as low molecular weight heparin or warfarin, with an INR within the therapeutic range for the anticoagulant, are eligible for screening).
- Normal pulmonary and cardiac function.
- Normal myocardial enzyme profile.
- No prior radiotherapy, chemotherapy, immunotherapy, or biological targeted therapy, or any other antitumor treatment for the current tumor lesion(s).
- Women of childbearing potential must have a negative pregnancy test (serum) within 7 days before enrollment and must voluntarily use appropriate contraception during the observation period and for 8 weeks after the last treatment; for men, they must be surgically sterile or agree to use appropriate contraception during the observation period and for 8 weeks after the last treatment.
- Participants must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule.
Who cannot join
- Has a history or presence of other malignancies, except for those that have been cured and with no evidence of disease for over 5 years (such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma, etc.).
- Has active autoimmune diseases or a history of autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); excluding autoimmune-mediated hypothyroidism stabilized with thyroid hormone replacement therapy; type I diabetes mellitus stabilized on insulin regimen; vitiligo or childhood asthma/allergies that have resolved and require no intervention in adulthood.
- Has uncontrolled cardiac clinical symptoms or diseases, such as: (a) NYHA Class II or above heart failure; (b) unstable angina; (c) myocardial infarction within the past year; (d) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
- Has severe infection (CTCAE > Grade 2) within 4 weeks prior to the first dose of the study drug, active infection during screening, or unexplained fever > 38.5°C before administration (tumor-related fever may be considered for inclusion).
- Has a history of allergy to any component of anti-PD-1 antibodies, paclitaxel-based drugs, or cisplatin.
- Prior radiotherapy, chemotherapy, immunotherapy (including PD-1, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, cancer vaccines, etc.), or biological targeted therapy for the current hypopharyngeal/laryngeal/oropharyngeal cancer.
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- Concurrent participation in another clinical study, unless it is an observational (non-interventional) study or the follow-up phase of an interventional study.
- Requirement for systemic treatment with corticosteroids (prednisone equivalent dose > 10 mg/day) or other immunosuppressive agents within 2 weeks prior to the first dose of the study drug, except for topical use to manage local inflammation, prevent allergies, or manage nausea and vomiting. Other special cases should be discussed with the investigator. Inhaled or topical steroids and physiological doses of corticosteroid replacement for adrenal insufficiency (≤ 10 mg/day prednisone equivalent) are permitted in the absence of active autoimmune disease.
- Major surgery or severe trauma within 4 weeks prior to the first dose of the study drug.
- Has a history of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation.
- Has a history of interstitial lung disease (excluding radiation pneumonitis not treated with steroids) or non-infectious pneumonitis.
- Has a history or CT evidence of active tuberculosis infection, or history of active tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year ago without formal treatment.
- Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL) or hepatitis C (positive HCV antibody with HCV-RNA above the lower limit of detection of the assay).
- Known history of drug abuse, alcohol abuse, or substance addiction
- Pregnant or lactating women.
- Other factors considered by the investigator that may lead to premature termination of the study, such as other severe diseases (including psychiatric disorders) requiring combined treatment, severely abnormal laboratory test values, family or social factors, or any other circumstances that may compromise subject safety or integrity of the study data.
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
Fudan Universtiy Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xin Zhou, M.D., +86 18017863989, zhoux1013@shca.org.cn
About this study
Official title: Induction Chemoimmunotherapy Followed by Concurrent Chemoradiotherapy and Adjuvant Immunotherapy Versus Concurrent Chemoradiotherapy Alone in Unresectable or Inoperable Locoregionally Advanced HPV-Negative Head and Neck Squamous Cell Carcinoma: A Randomized, Controlled, Phase 2 Study
The goal of this clinical trial is to evaluate if adding chemotherapy and immunotherapy as induction treatment prior to definitive chemoradiotherapy could improve the outcomes of locally advanced HPV-negative head and neck squamous cell that are not amenable to surgery. The study aims to answer:
- Does this treatment improve the survival outcomes of participants?
- How do the tumors of participants response to the treatment?
- How is the safety of this treatment? Researchers will compare this treatment (induction chemoimmunotherapy, followed by concurrent chemoradiotherapy, and then immunotherapy as maintenance therapy) to concurrent chemoradiotherapy to see whether it provides additional clinical benefits.
Read the detailed description
This multicenter, prospective, open-label, phase II randomized controlled clinical trial plans to enroll 104 treatment naïve participants with locally advanced (III-IVB by UICC/AJCC 8th), unresectable or inoperable HPV-negative head and neck squamous cell carcinoma (HNSCC). Patients will be stratified by primary tumor site (oropharynx vs. non-oropharynx) and randomly assigned (1:1) to one of two treatment arms: (1) Arm A (Experimental): Induction phase, three cycles of tislelizumab plus paclitaxel and cisplatin; Concurrent chemoradiotherapy (CCRT) phase, definitive radiotherapy concurrent with two cycles of cisplatin; Adjuvant phase, 13 cycles of tislelizumab. (2) Arm B (Comparator): CCRT, definitive radiotherapy concurrent with two cycles of cisplatin. The primary hypothesis is that the addition of induction chemoimmunotherapy and adjuvant immunotherapy improves event-free survival compared to chemoradiotherapy alone.
- Being tested
- Tislelizumab, Paclitaxel, Cisplatin (75 mg/m2), Intensity-Modulated Radiotherapy, Cisplatin (80 mg/m2)
- Keywords
- Head and Neck Squamous Cell Carcinoma, Programmed Cell Death Receptor 1 (PD-1), Chemotherapy, Chemoradiotherapy, Induction Treatment
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabBiological
Also called Tevimbra
- As induction immunotherapy, 200 mg administered IV infusion on Day 1 of each 21-day cycle, for 3 cycles.
- As adjuvant immunotherapy, 200 mg administered IV infusion on Day 1 of each 21-day cycle, for 13 cycles.
PaclitaxelDrug
- As induction chemotherapy, 175 mg/m2 administered IV infusion on Day 2 of each 21-day cycle, for 3 cycles.
Cisplatin (75 mg/m2)Drug
- As induction chemotherapy, 75 mg/m2 administered IV infusion on Day 2-4 of each 21-day cycle, for three cycles.
Intensity-Modulated RadiotherapyRadiation
Also called IMRT
- Definitive IMRT: 70Gy given in 35 fractions over 7 weeks
Cisplatin (80 mg/m2)Drug
- As concurrent chemotherapy, 80 mg/m2 administered IV infusion on Day 1-3 of each 21-day cycle, for two cycles.
| Study group | Role | What they receive |
|---|---|---|
| Induction tislelizumab/chemotherapy + CCRT + adjuvant tislelizumab | Experimental | Participants receive three cycles of induction chemoimmunotherapy (tislelizumab + paclitaxel-cisplatin) before initiation of CCRT. During CCRT, participants receive two cycles of concurrent cisplatin. After completion of radiotherapy, participants receive additional 13 cycles of adjuvant tislelizumab. Receives: Biological: Tislelizumab; Drug: Paclitaxel; Drug: Cisplatin (75 mg/m2); Radiation: Intensity-Modulated Radiotherapy; Drug: Cisplatin (80 mg/m2) |
| Concurrent Chemoradiotherapy | Active comparator | Participants receive standard-of-care CCRT, consisting of IMRT with a total dose of 70Gy and two cycles of concurrent cisplatin. Receives: Radiation: Intensity-Modulated Radiotherapy; Drug: Cisplatin (80 mg/m2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free Survival (EFS)
Defined as the time to the earliest occurrence of progressive disease that precluded chemoradiotherapy or prevented completion of chemoradiotherapy, disease recurrence, or death from any cause.
Measured: 2 year
Secondary outcomes (7)
Overall Survival (OS)
Defined as the time from randomization to death due to any cause.
Measured: 2 year
Locoregional Recurrence-Free Survival (LRFS)
Defined as the time from randomization to the first documented event of local or regional recurrence.
Measured: 2 year
Distant Metastasis-free survival (DMFS)
Defined as the time from randomization to the first documented event of distant metastasis.
Measured: 2 year
Objective Response Rate (ORR)
Defined as the proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST). ORR will be evaluated after induction treatment, CCRT, and adjuvant immunotherapy, respectively.
Measured: Through study completion, an average of 1 year
Incidence of Adverse Events
All adverse events will be documented, including treatment-emergent AEs (TEAEs) and immune-related AEs (irAEs), in the form of all-grade AEs and grade 3-4 AEs. AEs will be evaluated by investigators according to the Common Terminology Criteria for Adverse Events, version 5.0.
Measured: 2 year
Quality of Life (QoL) (EORTC QLQ-H&N35)
Changes in QoL of participants from baseline to up to 6 months after the completion of adjuvant immunotherapy. QoL will be evaluated with the questionnaires of the head-and-neck-specific module (H\&N35) of the Quality of Life Questionnaire-Core 30 module (QLQ-C30).
Measured: Baseline and up to 6 months
Quality of life (Qol) (FACT-HN)
Changes in QoL of participants from baseline to up to 6 months after the completion of adjuvant immunotherapy. QoL will be evaluated with the questionnaires of the general and head-and-neck-specific (HN) module of the evaluation tool developed by the Functional Assessment of Cancer Therapy (FACT).
Measured: Baseline and up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV-unrelated Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaosu Hu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776340
- Sponsor's protocol ID
- NACI-HN-FD
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Chemoimmunotherapy Followed by Concurrent Chemoradiotherapy and Adjuvant Immunotherapy Versus Concurrent Chemoradiotherapy Alone in Unresectable or Inoperable Locoregionally Advanced HPV-Negative Head and Neck Squamous Cell Carcinoma: A Randomized, Controlled, Phase 2 Study
- ClinicalTrials.gov ID
- NCT07776340
- Acronym / sponsor ID
- NACI-HN-FD
- Keywords
- Head and Neck Squamous Cell Carcinoma, Programmed Cell Death Receptor 1 (PD-1), Chemotherapy, Chemoradiotherapy, Induction Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 20 Aug 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.
The goal of this clinical trial is to evaluate if adding chemotherapy and immunotherapy as induction treatment prior to definitive chemoradiotherapy could improve the outcomes of locally advanced HPV-negative head and neck squamous cell that are not amenable to surgery. The study aims to answer:
- Does this treatment improve the survival outcomes of participants?
- How do the tumors of participants response to the treatment?
- How is the safety of this treatment? Researchers will compare this treatment (induction chemoimmunotherapy, followed by concurrent chemoradiotherapy, and then immunotherapy as maintenance therapy) to concurrent chemoradiotherapy to see whether it provides additional clinical benefits.
Detailed description
This multicenter, prospective, open-label, phase II randomized controlled clinical trial plans to enroll 104 treatment naïve participants with locally advanced (III-IVB by UICC/AJCC 8th), unresectable or inoperable HPV-negative head and neck squamous cell carcinoma (HNSCC). Patients will be stratified by primary tumor site (oropharynx vs. non-oropharynx) and randomly assigned (1:1) to one of two treatment arms: (1) Arm A (Experimental): Induction phase, three cycles of tislelizumab plus paclitaxel and cisplatin; Concurrent chemoradiotherapy (CCRT) phase, definitive radiotherapy concurrent with two cycles of cisplatin; Adjuvant phase, 13 cycles of tislelizumab. (2) Arm B (Comparator): CCRT, definitive radiotherapy concurrent with two cycles of cisplatin. The primary hypothesis is that the addition of induction chemoimmunotherapy and adjuvant immunotherapy improves event-free survival compared to chemoradiotherapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induction tislelizumab/chemotherapy + CCRT + adjuvant tislelizumab | Experimental | Biological: Tislelizumab, Drug: Paclitaxel, Drug: Cisplatin (75 mg/m2), Radiation: Intensity-Modulated Radiotherapy, Drug: Cisplatin (80 mg/m2)Participants receive three cycles of induction chemoimmunotherapy (tislelizumab + paclitaxel-cisplatin) before initiation of CCRT. During CCRT, participants receive two cycles of concurrent cisplatin. After completion of radiotherapy, participants receive additional 13 cycles of adjuvant tislelizumab. |
| Concurrent Chemoradiotherapy | Active comparator | Radiation: Intensity-Modulated Radiotherapy, Drug: Cisplatin (80 mg/m2)Participants receive standard-of-care CCRT, consisting of IMRT with a total dose of 70Gy and two cycles of concurrent cisplatin. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Pathologically confirmed HPV-negative head and neck squamous cell carcinoma (including laryngeal, hypopharyngeal, or oropharyngeal cancer).
- Loco-regionally advanced (Stage III-IVB) disease according to the 8th edition clinical staging system of the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC).
- Confirmed by a multidisciplinary team (MDT) as not amenable to curative surgery and deemed suitable for definitive concurrent chemoradiotherapy.
- "Not amenable to curative surgery" includes unresectable disease (anatomic impossibility of resection) or inoperable disease (patient medically unable to tolerate or declining surgical resection).
- ECOG performance status of 0-1.
Key exclusion criteria (16 listed)
- Has a history or presence of other malignancies, except for those that have been cured and with no evidence of disease for over 5 years (such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma, etc.).
- Has active autoimmune diseases or a history of autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); excluding autoimmune-mediated hypothyroidism stabilized with thyroid hormone replacement therapy; type I diabetes mellitus stabilized on insulin regimen; vitiligo or childhood asthma/allergies that have resolved and require no intervention in adulthood.
- Has uncontrolled cardiac clinical symptoms or diseases, such as: (a) NYHA Class II or above heart failure; (b) unstable angina; (c) myocardial infarction within the past year; (d) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
- Has severe infection (CTCAE > Grade 2) within 4 weeks prior to the first dose of the study drug, active infection during screening, or unexplained fever > 38.5°C before administration (tumor-related fever may be considered for inclusion).
- Has a history of allergy to any component of anti-PD-1 antibodies, paclitaxel-based drugs, or cisplatin.
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 |
|---|---|---|
| TislelizumabAlso: Tevimbra* As induction immunotherapy, 200 mg administered IV infusion on Day 1 of each 21-day cycle, for 3 cycles. * As adjuvant immunotherapy, 200 mg administered IV infusion on Day 1 of each 21-day cycle, for 13 cycles. | Biological | Induction tislelizumab/chemotherapy + CCRT + adjuvant tislelizumab |
| Paclitaxel- As induction chemotherapy, 175 mg/m2 administered IV infusion on Day 2 of each 21-day cycle, for 3 cycles. | Drug | Induction tislelizumab/chemotherapy + CCRT + adjuvant tislelizumab |
| Cisplatin (75 mg/m2)- As induction chemotherapy, 75 mg/m2 administered IV infusion on Day 2-4 of each 21-day cycle, for three cycles. | Drug | Induction tislelizumab/chemotherapy + CCRT + adjuvant tislelizumab |
| Intensity-Modulated RadiotherapyAlso: IMRT- Definitive IMRT: 70Gy given in 35 fractions over 7 weeks | Radiation | Concurrent Chemoradiotherapy, Induction tislelizumab/chemotherapy + CCRT + adjuvant tislelizumab |
| Cisplatin (80 mg/m2)- As concurrent chemotherapy, 80 mg/m2 administered IV infusion on Day 1-3 of each 21-day cycle, for two cycles. | Drug | Concurrent Chemoradiotherapy, Induction tislelizumab/chemotherapy + CCRT + adjuvant tislelizumab |
Primary outcome
Event-free Survival (EFS)
Time frame: 2 year
Defined as the time to the earliest occurrence of progressive disease that precluded chemoradiotherapy or prevented completion of chemoradiotherapy, disease recurrence, or death from any cause.
7 secondary outcomes
Overall Survival (OS)
Time frame: 2 year
Locoregional Recurrence-Free Survival (LRFS)
Time frame: 2 year
Distant Metastasis-free survival (DMFS)
Time frame: 2 year
Objective Response Rate (ORR)
Time frame: Through study completion, an average of 1 year
Incidence of Adverse Events
Time frame: 2 year
Quality of Life (QoL) (EORTC QLQ-H&N35)
Time frame: Baseline and up to 6 months
Quality of life (Qol) (FACT-HN)
Time frame: Baseline and up to 6 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 20 Aug 2026.
- 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 Phase 2 study testing Tislelizumab, Paclitaxel and Cisplatin (75 mg/m2) in people with HPV-unrelated Head and Neck Squamous Cell Carcinoma, run by Fudan 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 12 inclusion and 16 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 20 Aug 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xin Zhou, M.D. (+8618017863989, zhoux1013@shca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free Survival (EFS) (time frame: 2 year). 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 20 Aug 2026.