Locally Advanced Gastric CancerPhase 2DIAMC-GCNCT07638631
Ipilimumab (N01) Plus Sintilimab and Modified XELOX as Conversion Therapy in Unresectable Locally Advanced Gastric Cancer
A Phase 2 study testing Ipilimumab injection N01, Sintilimab and Modified (60% standard dose) XELOX in people with Locally Advanced Gastric Cancer, run by Chen Lizhu.
Trial summary
This study was a prospective, single-arm, multi-center, phase Ⅱ clinical study to investigate the efficacy and safety of ipilimumab injection N01 combined with sintilimab and modified XELOX conversion therapy in patients with unresectable locally advanced gastric cancer who had not received systemic treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Locally Advanced Gastric Cancer
- What is being tested?
- Ipilimumab injection N01, Sintilimab and Modified (60% standard dose) XELOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2026to 15 Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provided written informed consent before performing any trial-related procedures;
- Age ≥18 years old and ≤80 years old, regardless of gender;
- Histologically confirmed gastric or gastroesophageal junction adenocarcinoma, PDL1 CPS≥1, and unresectable locally advanced gastric cancer confirmed by MDT or investigator assessment (based on imaging and EUS assessment). Conclusions: The main reasons for unresectable locally advanced gastric cancer at initial diagnosis include: severe invasion of the primary tumor, inability to separate from surrounding organs or wrap around important blood vessels, or metastasis and fixation of regional lymph nodes, and inability to achieve R0 resection according to MDT discussion or investigator evaluation. R0 resection was considered unresectable if a Whipple's operation was performed in conjunction with it.
- At least one radiographic measurable lesion according to response evaluation Criteria in Solid Tumors (RECIST, version 1.1);
- No previous gastric cancer surgery, anti-tumor chemoradiotherapy/immunotherapy;
- ECOG score 0-1;
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- Expected survival time \> 6 months;
- Adequate organ function, subject must meet the following laboratory indicators:
- 1) absolute neutrophil count (ANC) ≥1.5x109/L without using granulocyte colony-stimulating factor for the past 14 days.
- 2) platelet count ≥75×109/L without blood transfusion in the past 14 days. 3) hemoglobin ≥75g/L without blood transfusion or erythropoietin use in the past 14 days; 4) Total bilirubin ≤3× upper limit of normal value (ULN); 5) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN; 6) serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥50 ml/min (exclusion due to height); 7) good coagulation function, defined as INR or PT ≤1.5 times ULN; 8) Euthyroid, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH was beyond the normal range, the subjects could be included if the total T3 (or FT3) and FT4 were within the normal range.
- 9. Myocardial enzymes within the normal range (simple laboratory abnormalities without clinical significance judged by the investigators were also allowed to be enrolled); 10. For women of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days before receiving the first dose of study drug (day 1 of cycle 1). If a urine pregnancy test result could not be confirmed as negative, a blood pregnancy test was requested. Women who were not of reproductive age were defined as those who had been postmenopausal for at least 1 year or had undergone surgical sterilization or hysterectomy.
- 11. If there was a risk of pregnancy, all subjects (male or female) were required to use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug on treatment (or 180 days after the last dose of chemotherapy drug).
Who cannot join
- Known HER2 positivity;
- Malignant diseases other than gastric cancer (excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, and/or radical resection in situ carcinoma) diagnosed within 5 years before the first dose;
- Are currently participating in an interventional clinical study treatment, or have received another study drug or investigational device within 4 weeks before the first dose;
- Previous therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent targeting another T-cell receptor that stimulates or coinhibits it (e.g., CTLA-4, OX-40, CD137);
- Active autoimmune disease leading to systemic therapy (e.g., disease-modifying agents, glucocorticoids, or immunosuppressive agents) occurred within 1 year before the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) were not considered systemic therapy;
- Receiving systemic glucocorticoids (excluding topical glucocorticoids by nasal spray, inhalation, or other route) or any other form of immunosuppressive therapy within 7 days before the first study dose; Note: Physiologic doses of glucocorticoids (≤10 mg per day of prednisone or equivalent) were allowed.
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- Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- Patients with known allergy to sintilimab, ipilimumab injection N01, chemotherapy active ingredients or excipients;
- Has not fully recovered from any intervention-related toxicity and/or complications before starting treatment (i.e., grade ≤1 or baseline, excluding fatigue or alopecia);
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive);
- Known signs of active bleeding on endoscopy and a history of gastrointestinal perforation and/or fistula within 6 months;
- Received anti-tumor Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control ascites) with systemic treatment within 2 weeks before the first dose;
- Uncontrolled active hepatitis B (defined as both HBsAg positivity and HBV-DNA copies greater than the upper limit of normal range in the laboratory of the research center);
- Note: Subjects with hepatitis B who met the following criteria were also eligible for inclusion:
- HBV viral load \< before the first administration; 1000 copies /ml (200 IU/ml), subjects should receive anti-HBV therapy throughout the study drug treatment to avoid viral reactivation
- For subjects with anti-HBc (+), HBsAg (-), anti-hbs (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but viral reactivation should be closely monitored 14. Active HCV-infected subjects (HCV-antibody positive and HCV-RNA level above the lower limit of detection); 15. Received a live vaccine within 30 days before the first dose (cycle 1, day 1); Note: Administration of injectable inactivated virus vaccine against seasonal influenza within 30 days before the first dose is allowed; Live, attenuated, intranasal influenza vaccine was not allowed.
- 16. Pregnant or lactating women; 17. The presence of any serious or uncontrolled systemic illness, such as:
- significant rhythm, conduction or morphological abnormalities in resting ECG, such as complete left bundle branch block, ≥ Ⅱ degree heart block, ventricular arrhythmia or atrial fibrillation;
- unstable angina, congestive heart failure, New York Heart Association (NYHA) grade ≥ 2 chronic heart failure;
- any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, etc. within 6 months before enrollment;
- poor blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);
- patients had a history of noninfectious pneumonia requiring glucocorticoid treatment within 1 year before the first dose of glucocorticoid, or current clinically active interstitial lung disease;
- active pulmonary tuberculosis;
- presence of active or uncontrolled infection requiring systemic therapy;
- presence of clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction;
- liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
- poorly controlled diabetes (fasting blood glucose (FBG) > 10mmol/L);
- Urine routine test showed urinary protein ≥++ and confirmed 24-hour urinary protein quantitation > 2.0 g;
- those with mental disorders who are unable to cooperate with treatment; 18. Medical history or evidence of disease, abnormal treatment or laboratory test results, or other conditions deemed by the investigator to be inappropriate for enrollment, or other potential risks considered by the investigator to be inappropriate for participation in the study that may interfere with the trial results or prevent the participant from participating in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm, Prospective, Multicenter Study of Ipilimumab (N01) Plus Sintilimab and Modified XELOX as Conversion Therapy in Unresectable Locally Advanced Gastric Cancer
This study was a prospective, single-arm, multi-center, phase Ⅱ clinical study to investigate the efficacy and safety of ipilimumab injection N01 combined with sintilimab and modified XELOX conversion therapy in patients with unresectable locally advanced gastric cancer who had not received systemic treatment.
Read the detailed description
This study was a prospective, single-arm, multi-center, phase Ⅱ clinical study to investigate the efficacy and safety of ipilimumab injection N01 combined with sintilimab and modified XELOX conversion therapy in patients with unresectable locally advanced gastric cancer who had not received systemic treatment.
After informed consent, 30 patients were selected and met the inclusion and exclusion criteria. Ipilimumab injection N01 was administered every 6 weeks (up to 4 cycles, according to the investigator's safety evaluation), sintilimab every 21 days, modified (60% standard dose) XELOX (oxaliplatin 78mg/m2, d1; Capecitabine 600mg/m2, bid, d1-14, q3w). Tumor assessments were performed every 8 weeks, and radical surgery was performed within 2-4 weeks after the last dose of study drug if the investigator assessed that it was feasible to perform radical surgery. If the evaluation showed that radical surgery could not be performed, the conversion therapy was continued until the evaluation was operable. Non-pd patients who were still inoperable continued to receive sintilimab combined with XELOX treatment, and PD patients were excluded from the group. Combination therapy was administered until disease progression or intolerable toxicity. After surgery, patients were treated with sintilimab combined with XELOX adjuvant therapy (the total number of chemotherapy cycles in the perioperative period was not more than 8 cycles, and the total treatment of sintilimab was 1 year according to the evaluation of the specific conditions of the patients), and ipilimumab injection N01 was treated with up to 4 cycles before surgery.
According to RECIST v1.1, preoperative imaging (CT/ enhanced CT) was performed to evaluate the efficacy and surgical evaluation. Postoperative imaging was assessed every three months until disease recurrence, and survival follow-up was performed every three months after recurrence. No more than 2 years. Safety visits were from the time of the first dose of dose until 60 days after the last dose or the initiation of a new antitumor therapy.
Biomarker blood and tumor samples, including tumor biopsies that may be performed at baseline or provided from other hospitals, will also be obtained at baseline and during the trial for participants who have signed up for biomarker sample collection.
- Conditions
- Locally Advanced Gastric Cancer
- Being tested
- Ipilimumab injection N01, Sintilimab, Modified (60% standard dose) XELOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipilimumab injection N01Drug
Ipilimumab injection N01 (R\&D Code: IBI310) is a recombinant fully human anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) monoclonal antibody independently developed by Xinda Biotechnology (Suzhou) Co., Ltd. It can specifically bind to CTLA-4 molecule, thereby blocking CTLA-4-mediated T cell suppression, promoting T cell activation and proliferation, and enhancing tumor immune response. To achieve anti-tumor effect.
SintilimabDrug
Sintilimab is a recombinant fully human IgG4 PD-1 monoclonal antibody, which is a Class 1 new drug independently developed by Xinda Biotechnology (Suzhou) Co., Ltd. Sintilimab can specifically bind to PD-1 molecules on the surface of T lymphocytes, thereby blocking the PD-1/PD-L1 pathway leading to tumor immune tolerance. To reactivate the anti-tumor activity of T lymphocytes and achieve the purpose of tumor treatment.
Modified (60% standard dose) XELOXDrug
Modified (60% standard dose) XELOX:
(Oxaliplatin 78mg/m2,d1; capecitabine 600mg/m2,bid,d1-14,q3w)
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Ipilimumab injection N01, every 6 weeks for cycles (up to 4 cycles), sintilimab every 21 days for cycles, modified (60% standard dose) XELOX (oxaliplatin 78mg/m2, d1; Capecitabine 600mg/m2, bid, d1-14, q3w). Tumor assessments were performed every 8 weeks, and radical surgery was performed within 2 to 4 weeks after the last dose of study drug if the investigator's assessment was feasible; If the evaluation showed that radical surgery could not be performed, the conversion therapy was continued until the evaluation was operable. Non-pd patients who were still inoperable continued to receive sintilimab combined with XELOX treatment, and PD patients were excluded from the group. Combination therapy was administered until disease progression or intolerable toxicity. Postoperative adjuvant treatment with sintilimab combined with XELOX (the total number of chemotherapy cycles in perioperative treatment should not exceed 8 cycles, and the total number of sintilimab treatment should be 1 year) Receives: Drug: Ipilimumab injection N01; Drug: Sintilimab; Drug: Modified (60% standard dose) XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical conversion rate
Ratio of subjects who underwent surgical resection to all subjects who received a conversion therapy regimen
Measured: 12 months
Secondary outcomes (4)
pCR rate
It was defined as the ratio of subjects with no viable tumor cells in the surgical resection specimen to all those who underwent surgery
Measured: 12 months
MPR rate
It was defined as the proportion of subjects with ≤10% viable tumor cells in the surgically resected specimen among all patients who underwent surgery
Measured: 12 months
ORR
It was defined as the ratio of complete remission (CR) and partial remission (PR) among the total subjects
Measured: 12 months
AEs
Measured: Baseline up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion15 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Gastric CancerStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Lizhu
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Chen Lizhu, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638631
- Sponsor's protocol ID
- DIAMC-GC
- Acronym
- DIAMC-GC
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 10 Jun 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 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Prospective, Multicenter Study of Ipilimumab (N01) Plus Sintilimab and Modified XELOX as Conversion Therapy in Unresectable Locally Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT07638631
- Acronym / sponsor ID
- DIAMC-GC / DIAMC-GC
- Conditions
- Locally Advanced Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chen LizhuOther government
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 15 Jun 2030 (estimated)
- First posted
- 10 Jun 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 study was a prospective, single-arm, multi-center, phase Ⅱ clinical study to investigate the efficacy and safety of ipilimumab injection N01 combined with sintilimab and modified XELOX conversion therapy in patients with unresectable locally advanced gastric cancer who had not received systemic treatment.
Detailed description
This study was a prospective, single-arm, multi-center, phase Ⅱ clinical study to investigate the efficacy and safety of ipilimumab injection N01 combined with sintilimab and modified XELOX conversion therapy in patients with unresectable locally advanced gastric cancer who had not received systemic treatment.
After informed consent, 30 patients were selected and met the inclusion and exclusion criteria. Ipilimumab injection N01 was administered every 6 weeks (up to 4 cycles, according to the investigator's safety evaluation), sintilimab every 21 days, modified (60% standard dose) XELOX (oxaliplatin 78mg/m2, d1; Capecitabine 600mg/m2, bid, d1-14, q3w). Tumor assessments were performed every 8 weeks, and radical surgery was performed within 2-4 weeks after the last dose of study drug if the investigator assessed that it was feasible to perform radical surgery. If the evaluation showed that radical surgery could not be performed, the conversion therapy was continued until the evaluation was operable. Non-pd patients who were still inoperable continued to receive sintilimab combined with XELOX treatment, and PD patients were excluded from the group. Combination therapy was administered until disease progression or intolerable toxicity. After surgery, patients were treated with sintilimab combined with XELOX adjuvant therapy (the total number of chemotherapy cycles in the perioperative period was not more than 8 cycles, and the total treatment of sintilimab was 1 year according to the evaluation of the specific conditions of the patients), and ipilimumab injection N01 was treated with up to 4 cycles before surgery.
According to RECIST v1.1, preoperative imaging (CT/ enhanced CT) was performed to evaluate the efficacy and surgical evaluation. Postoperative imaging was assessed every three months until disease recurrence, and survival follow-up was performed every three months after recurrence. No more than 2 years. Safety visits were from the time of the first dose of dose until 60 days after the last dose or the initiation of a new antitumor therapy.
Biomarker blood and tumor samples, including tumor biopsies that may be performed at baseline or provided from other hospitals, will also be obtained at baseline and during the trial for participants who have signed up for biomarker sample collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Ipilimumab injection N01, Drug: Sintilimab, Drug: Modified (60% standard dose) XELOXIpilimumab injection N01, every 6 weeks for cycles (up to 4 cycles), sintilimab every 21 days for cycles, modified (60% standard dose) XELOX (oxaliplatin 78mg/m2, d1; Capecitabine 600mg/m2, bid, d1-14, q3w). Tumor assessments were performed every 8 weeks, and radical surgery was performed within 2 to 4 weeks after the last dose of study drug if the investigator's assessment was feasible; If the evaluation showed that radical surgery could not be performed, the conversion therapy was continued until the evaluation was operable. Non-pd patients who were still inoperable continued to receive sintilimab combined with XELOX treatment, and PD patients were excluded from the group. Combination therapy was administered until disease progression or intolerable toxicity. Postoperative adjuvant treatment with sintilimab combined with XELOX (the total number of chemotherapy cycles in perioperative treatment should not exceed 8 cycles, and the total number of sintilimab treatment should be 1 year) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provided written informed consent before performing any trial-related procedures;
- Age ≥18 years old and ≤80 years old, regardless of gender;
- Histologically confirmed gastric or gastroesophageal junction adenocarcinoma, PDL1 CPS≥1, and unresectable locally advanced gastric cancer confirmed by MDT or investigator assessment (based on imaging and EUS assessment). Conclusions: The main reasons for unresectable locally advanced gastric cancer at initial diagnosis include: severe invasion of the primary tumor, inability to separate from surrounding organs or wrap around important blood vessels, or metastasis and fixation of regional lymph nodes, and inability to achieve R0 resection according to MDT discussion or investigator evaluation. R0 resection was considered unresectable if a Whipple's operation was performed in conjunction with it.
- At least one radiographic measurable lesion according to response evaluation Criteria in Solid Tumors (RECIST, version 1.1);
- No previous gastric cancer surgery, anti-tumor chemoradiotherapy/immunotherapy;
Key exclusion criteria (29 listed)
- Known HER2 positivity;
- Malignant diseases other than gastric cancer (excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, and/or radical resection in situ carcinoma) diagnosed within 5 years before the first dose;
- Are currently participating in an interventional clinical study treatment, or have received another study drug or investigational device within 4 weeks before the first dose;
- Previous therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent targeting another T-cell receptor that stimulates or coinhibits it (e.g., CTLA-4, OX-40, CD137);
- Active autoimmune disease leading to systemic therapy (e.g., disease-modifying agents, glucocorticoids, or immunosuppressive agents) occurred within 1 year before the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) were not considered systemic therapy;
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 |
|---|---|---|
| Ipilimumab injection N01Ipilimumab injection N01 (R\&D Code: IBI310) is a recombinant fully human anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) monoclonal antibody independently developed by Xinda Biotechnology (Suzhou) Co., Ltd. It can specifically bind to CTLA-4 molecule, thereby blocking CTLA-4-mediated T cell suppression, promoting T cell activation and proliferation, and enhancing tumor immune response. To achieve anti-tumor effect. | Drug | Single Arm |
| SintilimabSintilimab is a recombinant fully human IgG4 PD-1 monoclonal antibody, which is a Class 1 new drug independently developed by Xinda Biotechnology (Suzhou) Co., Ltd. Sintilimab can specifically bind to PD-1 molecules on the surface of T lymphocytes, thereby blocking the PD-1/PD-L1 pathway leading to tumor immune tolerance. To reactivate the anti-tumor activity of T lymphocytes and achieve the purpose of tumor treatment. | Drug | Single Arm |
| Modified (60% standard dose) XELOXModified (60% standard dose) XELOX: (Oxaliplatin 78mg/m2,d1; capecitabine 600mg/m2,bid,d1-14,q3w) | Drug | Single Arm |
Primary outcome
Surgical conversion rate
Time frame: 12 months
Ratio of subjects who underwent surgical resection to all subjects who received a conversion therapy regimen
4 secondary outcomes
pCR rate
Time frame: 12 months
MPR rate
Time frame: 12 months
ORR
Time frame: 12 months
AEs
Time frame: Baseline up to 3 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 10 Jun 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ipilimumab injection N01, Sintilimab and Modified (60% standard dose) XELOX in people with Locally Advanced Gastric Cancer, run by Chen Lizhu.
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 29 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 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Lizhu Chen, MD (86+15060035812, yiduoyun037@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical conversion rate (time frame: 12 months). 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 10 Jun 2026.