Esophageal CancerPhase 2BLESSNCT06385730
Neoadjuvant PD-1 Blockade for Elderly Esophageal Squamous Cell Carcinoma (BLESS)
A Phase 2 study testing neoadjuvant anti-PD-1 and neoadjuvant anti-PD-1 with LDRT in people with Esophageal Cancer, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
The investigators will conduct a prospective phase 2 study to evaluate the efficacy and safety of neoadjuvant PD-1 blockade monotherapy with toripalimab in elderly patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC). Read more about this study
- Who is it for?
- Ages 76 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- neoadjuvant anti-PD-1 and neoadjuvant anti-PD-1 with LDRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2024to May 2027
- 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 76 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects signed the informed consent and volunteered to participate in the study.
- Esophageal squamous cell carcinoma confirmed by histology or cytology.
- Thoracic esophageal squamous cell carcinoma confirmed by CT or pet-CT, which is classified as T1N1-3M0 or T2-3N0-3M0 (M1 lymph node metastasis confined to the supraclavicular lymph nodes) (AJCC 8th).
- Expect to have R0 resection
- In age >75.
- ECOG PS: 0~1.
Show all 11Show fewer
- Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, etc.
- No contraindications to surgery.
- Has sufficient organ function including (1) Blood routine: NE≥1.5×109/L; PLT≥100×109/L; HGB≥90 g/L (2)Comprehensive Metabolic Panel: bilirubin≤ 1.5×ULN; ALT≤2.5×ULN; AST≤2.5×ULN; sCr≤1.5×ULN or CrCl≥50 mL/min（Cocheroft-Gault) (3) Coagulation function: INR≤1.5.
- Women of childbearing age must undergo a serological pregnancy test within 72 hrs before first administration. Women of childbearing age, or male subjects with childbearing age female partners, must take contraceptive measures from the first dose to five months after last administration.
- Good compliance, willing to comply with follow-up schedules.
Who cannot join
- 1.Subjects have received or are receiving any of:
- anti-tumor interventions such as radiotherapy, chemotherapy, immunotherapy or other medictions.
- Received systemic corticosteroid therapy (prednisone equivalence> 10mg/d) or other immunosuppressive agents within the first 2 weeks prior to the first administration.
- live vaccine within 4 weeks before the first administration.
- 2. Cancer related exclusion criteria
- other cancers instead of ESCC
Show all 10Show fewer
- non-recetable or metastatic ESCC
- not comply with T1N1-3M0 or T2-3N0-3M0 (AJCC 8th).
- Subjects with other malignant tumors within 5 years before the first administration, but subjects with cervical carcinoma in situ, skin basal cell carcinoma, skin squamous cell carcinoma, and localized prostate cancer received radical surgery in situ that have received radical treatment and do not need other treatment can be included).
- 3. Other criteria Subjects have uncontrolled cardiovascular diseases, such as 1) heart failure ≥ NYHA class 2, 2) unstable angina 3) myocardial infarction within 1 year; 4) supraventricular or ventricular arrthymia that needs treatment Subjects with any known active autoimmune disease Pregnant or breastfeeding female Presence of allergy or hypersensitivity to investigational medications HIV positive or active hepatitis B (HbsAg positive and HBV-DNA ≥2000 IU/ml or ≥ 104 copies/mL) or active hepatitis C (HCV antibody positive) or active tuberculosis Investigators assessed there might be other factors that cause subjects to withdrawl.
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
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Zhigang Li, MD, PhD, 86-18960619260, zhigang.li@shsmu.edu.cn
About this study
Official title: Neoadjuvant PD-1 Blockade (Toripalimab) Monotherapy for Elderly Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: a Phase II Trial
The investigators will conduct a prospective phase 2 study to evaluate the efficacy and safety of neoadjuvant PD-1 blockade monotherapy with toripalimab in elderly patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC).
Read the detailed description
The incidence and mortality rates of esophageal cancer both rapidly increase after the age of 40 to 50 and peak after the age of 70 to 80. Clinical studies have shown that over 50% of esophageal cancer patients are diagnosed at an advanced local stage. Currently, the standard treatment recommended by guidelines for locally advanced esophageal cance is neoadjuvant chemoradiotherapy or chemotherapy. However, the phase III randomized controlled trials upon which these recommendations are based did not include patients over 75 years old. Therefore, for elderly patients aged over 75 with locally advanced esophageal cancer, there remains a lack of high-level evidence-based optimal neoadjuvant treatment strategies in clinical practice.
In Japan, neoadjuvant chemotherapy combined with surgery is the standard treatment for locally advanced esophageal cancer. A retrospective analysis (PMID: 35837977) conducted at 85 esophageal cancer centers certified by the Japan Esophageal Society examined patients with esophageal squamous cell carcinoma who received neoadjuvant CF (cisplatin + 5-fluorouracil) or intensified neoadjuvant DCF (docetaxel + cisplatin + 5-fluorouracil) regimens. The study results showed that the survival benefit of intensified neoadjuvant DCF was limited to patients aged ≤75 years. In patients older than 75 years, no survival advantage of intensified neoadjuvant DCF was observed, and the incidence of postoperative pneumonia was higher. The study suggested that elderly patients may not tolerate the toxic side effects of intensified neoadjuvant DCF triplet therapy. The high-intensity neoadjuvant triplet chemotherapy increased the incidence of postoperative complications in esophageal cancer, possibly offsetting the survival benefit in terms of tumor eradication.
A phase 1 trial conducted in 2023 (PMID: 37488287) demonstrated that neoadjuvant single-agent immunotherapy (atezolizumab) for locally advanced resectable esophageal squamous cell carcinoma is safe, with no Grade 3 or higher adverse reactions. The primary pathological response rate was 24%, with a complete pathological response rate of 8%. The 2-year overall survival rate was 92%, and the 2-year recurrence-free survival rate reached 100%. When compared with a historical control study (CMISG1701 study), the 2-year recurrence-free survival rate and 2-year overall survival rate with neoadjuvant single-agent immunotherapy were significantly higher, showing a statistically significant improvement compared to both standard neoadjuvant chemoradiotherapy (61% vs. 69%) and standard neoadjuvant chemotherapy (63% vs. 67%).
Based on (1) clinical evidence indicating higher adverse reactions and limited benefits of high-intensity neoadjuvant treatment regimens in elderly esophageal squamous cell carcinoma patients and (2) the potential advantages of neoadjuvant single-agent immunotherapy over standard neoadjuvant chemoradiotherapy or chemotherapy in terms of safety and survival benefits, this trial reasonably proposes a scientific research proposal-to explore the efficacy and safety of neoadjuvant immunotherapy monotherapy in elderly (aged over 75) patients with locally advanced thoracic esophageal squamous cell carcinoma under conditions of reduced combination therapy and decreased adverse reactions.
- Conditions
- Esophageal Cancer
- Being tested
- neoadjuvant anti-PD-1, neoadjuvant anti-PD-1 with LDRT
- Keywords
- esophageal cancer, immunotherapy, elderly patients
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neoadjuvant anti-PD-1Drug
PD-1 inhibitor (toripalimab) 240mg, day 1，every 3 weeks, 2 cycles. Postoperative adjuvant treatment: according to the recommendations of the guidelines and the investigators
neoadjuvant anti-PD-1 with LDRTDrug
Radiotherapy: low-dose radiotherapy (LDRT), gross target volume (GTV), DT: 1Gy (day1), 1Gy (day2), every 3 weeks, 2 cycles.
PD-1 inhibitor (toripalimab) 240mg, day 3，every 3 weeks, 2 cycles. Postoperative adjuvant treatment: according to the recommendations of the guidelines and the investigators
| Study group | Role | What they receive |
|---|---|---|
| neoadjuvant anti-PD-1 | Experimental | Drug: Immunotherapy Patients will receive the neoadjuvant immunotherapy with toripalimab followed by the esophagectomy. Receives: Drug: neoadjuvant anti-PD-1 |
| neoadjuvant anti-PD-1 with LDRT | Experimental | Drug: Immunotherapy Patients will receive the neoadjuvant low-dose radiotherapy plus immunotherapy with toripalimab followed by the esophagectomy. Receives: Drug: neoadjuvant anti-PD-1 with LDRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
MPR rate
A major pathological response rate (MPR) is defined as the proportion of residual living tumor cells in the post-surgery specimen within the tumor bed being less than or equal to 10%
Measured: Through the study completion, an average of 12 months
Secondary outcomes (7)
pCR rate
The primary endpoint is a pCR rate, which is defined as the absence of any remaining tumor cells in both the main tumor and the nearby lymph nodes (ypT0N0) as per the AJCC 8th Edition TRG scoring system
Measured: Through the study completion, an average of 12 months
Adverse events and treatment-related adverse events
Including adverse events and complications. Incidence of adverse events using CTCAE 5.0; grade 3 treatment-related adverse events and higher-grade will be reported
Measured: Through the study completion, an average of 12 months
R0 resection rate
A R0 resection rate is defined as the rate of complete tumor removal with negative resection margin microscopically
Measured: Through the study completion, an average of 12 months
Objective Response rate
objective response (according to the Response Evaluation Criteria In Solid Tumors, version 1.1)
Measured: Through the study completion, an average of 12 months
Event-free survival (EFS)
An event-free survival (EFS) is defined as the duration from the start of treatment until disease progression/recurrence or death from any cause, whichever occurs first.
Measured: Through the study completion, an average of 12 months
Overall survival (OS)
Overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence
Measured: Through the study completion, an average of 24 months
Correlation between potential biomarkers and tumor response
Tumor microenvironment (assessed by genomic sequencing) will be correlated with tumor response
Measured: Through the study completion, an average of 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start17 Jun 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhigang Li, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385730
- Sponsor's protocol ID
- SCE2401
- Acronym
- BLESS
- Status last verified
- Jun 2024
- First submitted
- 23 Apr 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yin J, Yuan J, Li Y, Fang Y, Wang R, Jiao H, Tang H, Zhang S, Lin S, Su F, Gu J, Jiang T, Lin D, Huang Z, Du C, Wu K, Tan L, Zhou Q. Neoadjuvant adebrelimab in locally advanced resectable esophageal squamous cell carcinoma: a phase 1b trial. Nat Med. 2023 Aug;29(8):2068-2078. doi: 10.1038/s41591-023-02469-3. Epub 2023 Jul 24.
PubMed 37488287Matsuda S, Kitagawa Y, Takemura R, Okui J, Okamura A, Kawakubo H, Muto M, Kakeji Y, Takeuchi H, Watanabe M, Doki Y. Real-world Evaluation of the Efficacy of Neoadjuvant DCF Over CF in Esophageal Squamous Cell Carcinoma: Propensity Score-matched Analysis From 85 Authorized Institutes for Esophageal Cancer in Japan. Ann Surg. 2023 Jul 1;278(1):e35-e42. doi: 10.1097/SLA.0000000000005533. Epub 2022 Jul 15.
PubMed 35837977Yang Y, Zhu L, Cheng Y, Liu Z, Cai X, Shao J, Zhang M, Liu J, Sun Y, Li Y, Yi J, Yu B, Jiang H, Chen H, Yang H, Tan L, Li Z. Three-arm phase II trial comparing camrelizumab plus chemotherapy versus camrelizumab plus chemoradiation versus chemoradiation as preoperative treatment for locally advanced esophageal squamous cell carcinoma (NICE-2 Study). BMC Cancer. 2022 May 6;22(1):506. doi: 10.1186/s12885-022-09573-6.
PubMed 35524205
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant PD-1 Blockade (Toripalimab) Monotherapy for Elderly Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: a Phase II Trial
- ClinicalTrials.gov ID
- NCT06385730
- Acronym / sponsor ID
- BLESS / SCE2401
- Conditions
- Esophageal Cancer
- Keywords
- esophageal cancer, immunotherapy, elderly patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 26 Apr 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.
The investigators will conduct a prospective phase 2 study to evaluate the efficacy and safety of neoadjuvant PD-1 blockade monotherapy with toripalimab in elderly patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC).
Detailed description
The incidence and mortality rates of esophageal cancer both rapidly increase after the age of 40 to 50 and peak after the age of 70 to 80. Clinical studies have shown that over 50% of esophageal cancer patients are diagnosed at an advanced local stage. Currently, the standard treatment recommended by guidelines for locally advanced esophageal cance is neoadjuvant chemoradiotherapy or chemotherapy. However, the phase III randomized controlled trials upon which these recommendations are based did not include patients over 75 years old. Therefore, for elderly patients aged over 75 with locally advanced esophageal cancer, there remains a lack of high-level evidence-based optimal neoadjuvant treatment strategies in clinical practice.
In Japan, neoadjuvant chemotherapy combined with surgery is the standard treatment for locally advanced esophageal cancer. A retrospective analysis (PMID: 35837977) conducted at 85 esophageal cancer centers certified by the Japan Esophageal Society examined patients with esophageal squamous cell carcinoma who received neoadjuvant CF (cisplatin + 5-fluorouracil) or intensified neoadjuvant DCF (docetaxel + cisplatin + 5-fluorouracil) regimens. The study results showed that the survival benefit of intensified neoadjuvant DCF was limited to patients aged ≤75 years. In patients older than 75 years, no survival advantage of intensified neoadjuvant DCF was observed, and the incidence of postoperative pneumonia was higher. The study suggested that elderly patients may not tolerate the toxic side effects of intensified neoadjuvant DCF triplet therapy. The high-intensity neoadjuvant triplet chemotherapy increased the incidence of postoperative complications in esophageal cancer, possibly offsetting the survival benefit in terms of tumor eradication.
A phase 1 trial conducted in 2023 (PMID: 37488287) demonstrated that neoadjuvant single-agent immunotherapy (atezolizumab) for locally advanced resectable esophageal squamous cell carcinoma is safe, with no Grade 3 or higher adverse reactions. The primary pathological response rate was 24%, with a complete pathological response rate of 8%. The 2-year overall survival rate was 92%, and the 2-year recurrence-free survival rate reached 100%. When compared with a historical control study (CMISG1701 study), the 2-year recurrence-free survival rate and 2-year overall survival rate with neoadjuvant single-agent immunotherapy were significantly higher, showing a statistically significant improvement compared to both standard neoadjuvant chemoradiotherapy (61% vs. 69%) and standard neoadjuvant chemotherapy (63% vs. 67%).
Based on (1) clinical evidence indicating higher adverse reactions and limited benefits of high-intensity neoadjuvant treatment regimens in elderly esophageal squamous cell carcinoma patients and (2) the potential advantages of neoadjuvant single-agent immunotherapy over standard neoadjuvant chemoradiotherapy or chemotherapy in terms of safety and survival benefits, this trial reasonably proposes a scientific research proposal-to explore the efficacy and safety of neoadjuvant immunotherapy monotherapy in elderly (aged over 75) patients with locally advanced thoracic esophageal squamous cell carcinoma under conditions of reduced combination therapy and decreased adverse reactions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neoadjuvant anti-PD-1 | Experimental | Drug: neoadjuvant anti-PD-1Drug: Immunotherapy Patients will receive the neoadjuvant immunotherapy with toripalimab followed by the esophagectomy. |
| neoadjuvant anti-PD-1 with LDRT | Experimental | Drug: neoadjuvant anti-PD-1 with LDRTDrug: Immunotherapy Patients will receive the neoadjuvant low-dose radiotherapy plus immunotherapy with toripalimab followed by the esophagectomy. |
Who may qualify
- Ages
- 76 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Subjects signed the informed consent and volunteered to participate in the study.
- Esophageal squamous cell carcinoma confirmed by histology or cytology.
- Thoracic esophageal squamous cell carcinoma confirmed by CT or pet-CT, which is classified as T1N1-3M0 or T2-3N0-3M0 (M1 lymph node metastasis confined to the supraclavicular lymph nodes) (AJCC 8th).
- Expect to have R0 resection
- In age >75.
Key exclusion criteria (10 listed)
- anti-tumor interventions such as radiotherapy, chemotherapy, immunotherapy or other medictions.
- Received systemic corticosteroid therapy (prednisone equivalence> 10mg/d) or other immunosuppressive agents within the first 2 weeks prior to the first administration.
- live vaccine within 4 weeks before the first administration.
- 2. Cancer related exclusion criteria
- other cancers instead of ESCC
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 |
|---|---|---|
| neoadjuvant anti-PD-1PD-1 inhibitor (toripalimab) 240mg, day 1，every 3 weeks, 2 cycles. Postoperative adjuvant treatment: according to the recommendations of the guidelines and the investigators | Drug | neoadjuvant anti-PD-1 |
| neoadjuvant anti-PD-1 with LDRTRadiotherapy: low-dose radiotherapy (LDRT), gross target volume (GTV), DT: 1Gy (day1), 1Gy (day2), every 3 weeks, 2 cycles. PD-1 inhibitor (toripalimab) 240mg, day 3，every 3 weeks, 2 cycles. Postoperative adjuvant treatment: according to the recommendations of the guidelines and the investigators | Drug | neoadjuvant anti-PD-1 with LDRT |
Primary outcome
MPR rate
Time frame: Through the study completion, an average of 12 months
A major pathological response rate (MPR) is defined as the proportion of residual living tumor cells in the post-surgery specimen within the tumor bed being less than or equal to 10%
7 secondary outcomes
pCR rate
Time frame: Through the study completion, an average of 12 months
Adverse events and treatment-related adverse events
Time frame: Through the study completion, an average of 12 months
R0 resection rate
Time frame: Through the study completion, an average of 12 months
Objective Response rate
Time frame: Through the study completion, an average of 12 months
Event-free survival (EFS)
Time frame: Through the study completion, an average of 12 months
Overall survival (OS)
Time frame: Through the study completion, an average of 24 months
Correlation between potential biomarkers and tumor response
Time frame: Through the study completion, an average of 36 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 1 Jul 2024.
- Background: PubMed 37488287Yin J, Yuan J, Li Y, Fang Y, Wang R, Jiao H, Tang H, Zhang S, Lin S, Su F, Gu J, Jiang T, Lin D, Huang Z, Du C, Wu K, Tan L, Zhou Q. Neoadjuvant adebrelimab in locally advanced resectable esophageal squamous cell carcinoma: a phase 1b trial. Nat Med. 2023 Aug;29(8):2068-2078. doi: 10.1038/s41591-023-02469-3. Epub 2023 Jul 24.
- Background: PubMed 35837977Matsuda S, Kitagawa Y, Takemura R, Okui J, Okamura A, Kawakubo H, Muto M, Kakeji Y, Takeuchi H, Watanabe M, Doki Y. Real-world Evaluation of the Efficacy of Neoadjuvant DCF Over CF in Esophageal Squamous Cell Carcinoma: Propensity Score-matched Analysis From 85 Authorized Institutes for Esophageal Cancer in Japan. Ann Surg. 2023 Jul 1;278(1):e35-e42. doi: 10.1097/SLA.0000000000005533. Epub 2022 Jul 15.
- Background: PubMed 35524205Yang Y, Zhu L, Cheng Y, Liu Z, Cai X, Shao J, Zhang M, Liu J, Sun Y, Li Y, Yi J, Yu B, Jiang H, Chen H, Yang H, Tan L, Li Z. Three-arm phase II trial comparing camrelizumab plus chemotherapy versus camrelizumab plus chemoradiation versus chemoradiation as preoperative treatment for locally advanced esophageal squamous cell carcinoma (NICE-2 Study). BMC Cancer. 2022 May 6;22(1):506. doi: 10.1186/s12885-022-09573-6.
- 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 neoadjuvant anti-PD-1 and neoadjuvant anti-PD-1 with LDRT in people with Esophageal Cancer, run by Shanghai Chest Hospital 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: looking for participants now, as of the sponsor's last update on 1 Jul 2024. 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 Zhigang Li, MD, PhD (86-18960619260, zhigang.li@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MPR rate (time frame: Through the study completion, an average of 12 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 NCT06385730, which also lists 3 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 1 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.