Thymoma and Thymic CarcinomaPhase 2/3NCT07463313
6 vs 3 Cycles of Neoadjuvant Chemotherapy for Potentially Resectable Locally Advanced Thymic Epithelial Tumors
A Phase 2/3 study testing Cyclophosphamide, Doxorubicin, and Cisplatin (CAP) and nab-Paclitaxel and Carboplatin in people with Thymoma and Thymic Carcinoma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This randomized controlled trial compares 6 versus 3 cycles of neoadjuvant chemotherapy in patients with potentially resectable locally advanced thymic epithelial tumors (TETs, WHO type AB/B/C, AJCC TNM stage IIIA-IVA). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thymoma and Thymic Carcinoma
- What is being tested?
- Cyclophosphamide, Doxorubicin, and Cisplatin (CAP) and nab-Paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- Mar 2026to Mar 2032
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed thymic epithelial tumor (thymoma or thymic carcinoma)
- Locally advanced, potentially resectable disease (Masaoka-Koga stage III or IVA), as evaluated by a multidisciplinary team (MDT) including thoracic surgery and thoracic oncology
- Age 18 to 65 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L
- Adequate liver function: total bilirubin ≤1.5× upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN
Show all 11Show fewer
- Adequate renal function: creatinine clearance ≥50 mL/min (Cockcroft-Gault formula)
- No prior systemic anticancer therapy for thymic epithelial tumor
- At least one measurable lesion per RECIST v1.1
- Willing to accept randomization and able to comply with study procedures
- Written informed consent obtained prior to any study-related procedures
Who cannot join
- Prior chemotherapy, targeted therapy, or immunotherapy for thymic epithelial tumor
- Prior thoracic radiation therapy
- Active autoimmune disease requiring systemic treatment within the past 2 years
- Known hypersensitivity or contraindication to study drugs (cisplatin, epirubicin, etoposide, ifosfamide, or any component of these formulations)
- Severe cardiac dysfunction: New York Heart Association (NYHA) class III or IV heart failure, or left ventricular ejection fraction (LVEF) <50%
- Active hepatitis B (HBsAg positive with HBV DNA ≥2000 IU/mL), active hepatitis C, or known HIV infection
Show all 10Show fewer
- Pregnancy or lactation; women of childbearing potential unwilling to use adequate contraception
- Other malignancy within 5 years prior to enrollment, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
- Uncontrolled active infection requiring systemic therapy
- Any condition that, in the investigator's judgment, would preclude safe participation in the study
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
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200080
Fan Jiang, MD, PhD, 86-21-63240090, fan_jiang@sjtu.edu.cn
About this study
Official title: A Randomized Controlled Trial of 6 Versus 3 Cycles of Neoadjuvant Chemotherapy on Event-Free Survival in Patients With Potentially Resectable Locally Advanced Thymic Epithelial Tumors
This randomized controlled trial compares 6 versus 3 cycles of neoadjuvant chemotherapy in patients with potentially resectable locally advanced thymic epithelial tumors (TETs, WHO type AB/B/C, AJCC TNM stage IIIA-IVA). Patients are randomized 1:1 to receive either 6 or 3 cycles of chemotherapy (cisplatin + doxorubicin + cyclophosphamide for type B; nab-paclitaxel + carboplatin for type C thymoma/thymic carcinoma) every 3 weeks, followed by surgical resection when feasible. The primary endpoint is event-free survival (EFS). The study aims to determine whether extended neoadjuvant chemotherapy improves surgical outcomes and long-term survival in this rare malignancy.
Read the detailed description
Thymic epithelial tumors (TETs) are rare mediastinal malignancies. Locally advanced, potentially resectable TETs present a significant clinical challenge, with limited prospective data on optimal neoadjuvant chemotherapy duration. Retrospective data from Shanghai General Hospital suggest that 6 cycles of neoadjuvant chemotherapy may yield higher objective response rates (75% vs 33.3%) and R0 resection rates (68.75% vs 33.33%) compared to 3 cycles.
This is a single-center, prospective, open-label, randomized controlled trial. Eligible patients are adults (18-65 years) with histologically confirmed WHO type AB, B1, B2, B3 thymoma or thymic carcinoma (type C), AJCC TNM stage IIIA-IVA, deemed potentially resectable by multidisciplinary team (MDT) evaluation, ECOG PS 0-1, with adequate organ function, no prior anti-tumor therapy.
Randomization: 1:1, stratified by histological subtype (type B vs type C), using central randomization with block size 4.
Treatment:
- Type B thymoma arm: cisplatin 50 mg/m² + doxorubicin 50 mg/m² + cyclophosphamide 500 mg/m², Q3W
- Type C thymic carcinoma arm: nab-paclitaxel 200 mg/m² + carboplatin AUC 5, Q3W
- Control group: 3 cycles; Experimental group: 6 cycles
Imaging assessment (RECIST 1.1) every 2 cycles. CR/PR: proceed to surgery; SD: continue chemotherapy; PD: radical radiotherapy.
Post-operative radiotherapy as indicated (R0: 45-50 Gy; R1: 54 Gy; R2: 60-70 Gy).
Primary endpoint: Event-Free Survival (EFS), defined as time from randomization to first occurrence of tumor recurrence, progression, or death.
Sample size: 116 patients (58 per arm), based on ORR comparison (25% vs 50%, α=0.05, power=0.80, 5% dropout/year).
Follow-up: 3 years post-enrollment (total study duration 6 years).
- Conditions
- Thymoma and Thymic Carcinoma
- Being tested
- Cyclophosphamide, Doxorubicin, and Cisplatin (CAP), nab-Paclitaxel and Carboplatin
- Keywords
- Neoadjuvant Chemotherapy, Thymic Epithelial Tumor, Thymic Carcinoma, Event-Free Survival, Mediastinal Tumor
- Medical subject headings
- Thymoma, Thymic epithelial tumor, Mediastinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclophosphamide, Doxorubicin, and Cisplatin (CAP)Drug
Chemotherapy regimen for WHO type B thymoma. Cyclophosphamide 500 mg/m2 IV + Doxorubicin 50 mg/m2 IV + Cisplatin 50 mg/m2 IV, administered every 3 weeks. Experimental arm receives 6 cycles; Control arm receives 3 cycles prior to surgery.
nab-Paclitaxel and CarboplatinDrug
Chemotherapy regimen for thymic carcinoma. nab-Paclitaxel 260 mg/m2 IV + Carboplatin AUC 5 IV, administered every 3 weeks. Experimental arm receives 6 cycles; Control arm receives 3 cycles prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| 6-Cycle Neoadjuvant Chemotherapy | Experimental | Participants receive 6 cycles of neoadjuvant chemotherapy prior to surgery. For WHO type B thymoma: cyclophosphamide 500 mg/m2 IV + doxorubicin 50 mg/m2 IV + cisplatin 50 mg/m2 IV (CAP regimen), every 3 weeks. For thymic carcinoma: nab-paclitaxel 260 mg/m2 IV + carboplatin AUC 5 IV, every 3 weeks. Receives: Drug: Cyclophosphamide, Doxorubicin, and Cisplatin (CAP); Drug: nab-Paclitaxel and Carboplatin |
| 3-Cycle Neoadjuvant Chemotherapy | Active comparator | Participants receive 3 cycles of neoadjuvant chemotherapy prior to surgery. For WHO type B thymoma: cyclophosphamide 500 mg/m2 IV + doxorubicin 50 mg/m2 IV + cisplatin 50 mg/m2 IV (CAP regimen), every 3 weeks. For thymic carcinoma: nab-paclitaxel 260 mg/m2 IV + carboplatin AUC 5 IV, every 3 weeks. Receives: Drug: Cyclophosphamide, Doxorubicin, and Cisplatin (CAP); Drug: nab-Paclitaxel and Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival (EFS)
EFS is defined as the time from randomization to the first occurrence of any of the following events: disease progression precluding surgery, incomplete resection (R1/R2), local or distant recurrence after surgery, or death from any cause.
Measured: 3 years from randomization
Secondary outcomes (6)
Objective Response Rate (ORR)
Proportion of participants achieving complete response (CR) or partial response (PR) per RECIST v1.1 criteria after neoadjuvant chemotherapy.
Measured: After completion of neoadjuvant chemotherapy (approximately 9 weeks for 3-cycle arm; approximately 18 weeks for 6-cycle arm)
3-Year Event-Free Survival Rate
Proportion of participants who remain free of events (disease progression, incomplete resection, recurrence, or death) at 3 years after randomization.
Measured: 3 years from randomization
R0 Resection Rate
Proportion of participants achieving complete (R0) resection, defined as microscopically negative surgical margins at the time of surgery.
Measured: At the time of surgery
Pathological Complete Response (pCR) Rate
Proportion of participants achieving pathological complete response (pCR), defined as no viable tumor cells in the surgical resection specimen, as assessed by central pathology review.
Measured: At the time of surgery
Major Pathological Response (MPR) Rate
Proportion of participants achieving major pathological response (MPR), defined as ≤10% residual viable tumor cells in the surgical resection specimen, as assessed by central pathology review.
Measured: At the time of surgery
Incidence and Severity of Adverse Events
Incidence, nature, and severity of adverse events and serious adverse events as assessed by NCI CTCAE v5.0, including hematologic toxicity, non-hematologic toxicity, and treatment-related deaths.
Measured: Throughout the study, from first dose to 30 days after last dose of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thymoma and Thymic CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiang Fan, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Fan Jiang, MD, PhD, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463313
- Sponsor's protocol ID
- 20251109101922438
- Other IDs
- 2026HS060
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared at this time due to patient privacy concerns and regulatory requirements. Aggregate data will be published in peer-reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of 6 Versus 3 Cycles of Neoadjuvant Chemotherapy on Event-Free Survival in Patients With Potentially Resectable Locally Advanced Thymic Epithelial Tumors
- ClinicalTrials.gov ID
- NCT07463313
- Acronym / sponsor ID
- 20251109101922438
- Conditions
- Thymoma and Thymic Carcinoma
- Keywords
- Neoadjuvant Chemotherapy, Thymic Epithelial Tumor, Thymic Carcinoma, Event-Free Survival, Mediastinal Tumor
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 11 Mar 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.
This randomized controlled trial compares 6 versus 3 cycles of neoadjuvant chemotherapy in patients with potentially resectable locally advanced thymic epithelial tumors (TETs, WHO type AB/B/C, AJCC TNM stage IIIA-IVA). Patients are randomized 1:1 to receive either 6 or 3 cycles of chemotherapy (cisplatin + doxorubicin + cyclophosphamide for type B; nab-paclitaxel + carboplatin for type C thymoma/thymic carcinoma) every 3 weeks, followed by surgical resection when feasible. The primary endpoint is event-free survival (EFS). The study aims to determine whether extended neoadjuvant chemotherapy improves surgical outcomes and long-term survival in this rare malignancy.
Detailed description
Thymic epithelial tumors (TETs) are rare mediastinal malignancies. Locally advanced, potentially resectable TETs present a significant clinical challenge, with limited prospective data on optimal neoadjuvant chemotherapy duration. Retrospective data from Shanghai General Hospital suggest that 6 cycles of neoadjuvant chemotherapy may yield higher objective response rates (75% vs 33.3%) and R0 resection rates (68.75% vs 33.33%) compared to 3 cycles.
This is a single-center, prospective, open-label, randomized controlled trial. Eligible patients are adults (18-65 years) with histologically confirmed WHO type AB, B1, B2, B3 thymoma or thymic carcinoma (type C), AJCC TNM stage IIIA-IVA, deemed potentially resectable by multidisciplinary team (MDT) evaluation, ECOG PS 0-1, with adequate organ function, no prior anti-tumor therapy.
Randomization: 1:1, stratified by histological subtype (type B vs type C), using central randomization with block size 4.
Treatment:
- Type B thymoma arm: cisplatin 50 mg/m² + doxorubicin 50 mg/m² + cyclophosphamide 500 mg/m², Q3W
- Type C thymic carcinoma arm: nab-paclitaxel 200 mg/m² + carboplatin AUC 5, Q3W
- Control group: 3 cycles; Experimental group: 6 cycles
Imaging assessment (RECIST 1.1) every 2 cycles. CR/PR: proceed to surgery; SD: continue chemotherapy; PD: radical radiotherapy.
Post-operative radiotherapy as indicated (R0: 45-50 Gy; R1: 54 Gy; R2: 60-70 Gy).
Primary endpoint: Event-Free Survival (EFS), defined as time from randomization to first occurrence of tumor recurrence, progression, or death.
Sample size: 116 patients (58 per arm), based on ORR comparison (25% vs 50%, α=0.05, power=0.80, 5% dropout/year).
Follow-up: 3 years post-enrollment (total study duration 6 years).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6-Cycle Neoadjuvant Chemotherapy | Experimental | Drug: Cyclophosphamide, Doxorubicin, and Cisplatin (CAP), Drug: nab-Paclitaxel and CarboplatinParticipants receive 6 cycles of neoadjuvant chemotherapy prior to surgery. For WHO type B thymoma: cyclophosphamide 500 mg/m2 IV + doxorubicin 50 mg/m2 IV + cisplatin 50 mg/m2 IV (CAP regimen), every 3 weeks. For thymic carcinoma: nab-paclitaxel 260 mg/m2 IV + carboplatin AUC 5 IV, every 3 weeks. |
| 3-Cycle Neoadjuvant Chemotherapy | Active comparator | Drug: Cyclophosphamide, Doxorubicin, and Cisplatin (CAP), Drug: nab-Paclitaxel and CarboplatinParticipants receive 3 cycles of neoadjuvant chemotherapy prior to surgery. For WHO type B thymoma: cyclophosphamide 500 mg/m2 IV + doxorubicin 50 mg/m2 IV + cisplatin 50 mg/m2 IV (CAP regimen), every 3 weeks. For thymic carcinoma: nab-paclitaxel 260 mg/m2 IV + carboplatin AUC 5 IV, every 3 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically or cytologically confirmed thymic epithelial tumor (thymoma or thymic carcinoma)
- Locally advanced, potentially resectable disease (Masaoka-Koga stage III or IVA), as evaluated by a multidisciplinary team (MDT) including thoracic surgery and thoracic oncology
- Age 18 to 65 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L
Key exclusion criteria (10 listed)
- Prior chemotherapy, targeted therapy, or immunotherapy for thymic epithelial tumor
- Prior thoracic radiation therapy
- Active autoimmune disease requiring systemic treatment within the past 2 years
- Known hypersensitivity or contraindication to study drugs (cisplatin, epirubicin, etoposide, ifosfamide, or any component of these formulations)
- Severe cardiac dysfunction: New York Heart Association (NYHA) class III or IV heart failure, or left ventricular ejection fraction (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 |
|---|---|---|
| Cyclophosphamide, Doxorubicin, and Cisplatin (CAP)Chemotherapy regimen for WHO type B thymoma. Cyclophosphamide 500 mg/m2 IV + Doxorubicin 50 mg/m2 IV + Cisplatin 50 mg/m2 IV, administered every 3 weeks. Experimental arm receives 6 cycles; Control arm receives 3 cycles prior to surgery. | Drug | 3-Cycle Neoadjuvant Chemotherapy, 6-Cycle Neoadjuvant Chemotherapy |
| nab-Paclitaxel and CarboplatinChemotherapy regimen for thymic carcinoma. nab-Paclitaxel 260 mg/m2 IV + Carboplatin AUC 5 IV, administered every 3 weeks. Experimental arm receives 6 cycles; Control arm receives 3 cycles prior to surgery. | Drug | 3-Cycle Neoadjuvant Chemotherapy, 6-Cycle Neoadjuvant Chemotherapy |
Primary outcome
Event-Free Survival (EFS)
Time frame: 3 years from randomization
EFS is defined as the time from randomization to the first occurrence of any of the following events: disease progression precluding surgery, incomplete resection (R1/R2), local or distant recurrence after surgery, or death from any cause.
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: After completion of neoadjuvant chemotherapy (approximately 9 weeks for 3-cycle arm; approximately 18 weeks for 6-cycle arm)
3-Year Event-Free Survival Rate
Time frame: 3 years from randomization
R0 Resection Rate
Time frame: At the time of surgery
Pathological Complete Response (pCR) Rate
Time frame: At the time of surgery
Major Pathological Response (MPR) Rate
Time frame: At the time of surgery
Incidence and Severity of Adverse Events
Time frame: Throughout the study, from first dose to 30 days after last dose of chemotherapy
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 11 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared at this time due to patient privacy concerns and regulatory requirements. Aggregate data will be published in peer-reviewed journals.
Related trials for Thymoma and Thymic Carcinoma
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 1
Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma
Mesothelioma, Neoplasms
Active, not recruitingPhase 2
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma
Active, not recruitingPhase 1
A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers
Carcinoma, Non-Small-Cell Lung, Cutaneous Melanoma
Not yet recruitingPhase 2
Phase II Trial of Hypofractionated Radiotherapy Guided by Optical Surface Imaging and Fan-beam CT for Thymoma With Pleural Metastasis
Thymoma and Thymic Carcinoma, Pleural Metastasis
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.
Fan Jiang, MD, PhD principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cyclophosphamide, Doxorubicin, and Cisplatin (CAP) and nab-Paclitaxel and Carboplatin in people with Thymoma and Thymic Carcinoma, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 11 inclusion and 10 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 11 Mar 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fan Jiang, MD, PhD (86-21-63240090, fan_jiang@sjtu.edu.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: 3 years from randomization). 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 11 Mar 2026.