Gastric CancerPhase 2ROSETTENCT06468280

Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric Cancer

A Phase 2 study testing Local treatment (Surgical), PD-1 Monoclonal Antibody and XELOX/SOX Chemotherapy Regimen in people with Gastric Cancer and GastroEsophageal Cancer, run by Shanghai Zhongshan Hospital at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 79 years
Conditions the study is for: Gastric Cancer, GastroEsophageal Cancer
What is being tested?: Local treatment (Surgical), PD-1 Monoclonal Antibody and XELOX/SOX Chemotherapy Regimen
Type of treatment: Pill or oral medicine, Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 2 sitesChina
Study dates: 8 Nov 2024to Dec 2028
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 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men or women aged 18-79.
Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (Siewert II or III only) with known PD-L1 expression status.
Gastric cancer with proficient mismatch repair (pMMR) or microsatellite stability (MSS) as determined by immunohistochemistry or NCI-recommended microsatellite markers.
Primary gastric cancer lesions are resectable, with limited distant metastases meeting the either of the following criteria: (1) condition (a) only; (2) any single condition from (b), with or without (a).
Non-regional intra-abdominal lymph node metastasis: Include metastasis to the superior mesenteric artery, middle colic artery, and para-aortic/retroperitoneal nodes (according to AJCC 8th edition standards).
(b1) Localized peritoneal metastasis: P0CY1, P1a, or P1b, according to the Japanese Classification of Gastric Carcinoma (15th edition).

Show all 15Show fewer

(b2) Liver metastasis: Up to 5 metastatic lesions. (b3) Lung metastasis: Up to 5 unilateral metastatic lesions. (b4) Ovarian metastasis: Unilateral or bilateral. (b5) Adrenal metastasis: Unilateral or bilateral. (b6) Single-region extra-abdominal lymph node metastasis: Such as cervical, supraclavicular, or mediastinal lymph nodes.
(b7) Bone metastasis limited to a single radiation field. (b8) Other limited metastases as determined by the research team.
No previous anti-tumor treatments.
ECOG score ≤2, no surgical contraindications.
Life expectancy ≥ 3 months.
Physical condition and organ function suitable for major abdominal surgery.
Willingness and ability to comply with the study protocol.
Fertile women with a negative urine or serum pregnancy test and agreement to use effective contraception during the study and for 180 days after the last dose. Non-sterilized men must also agree to use effective contraception.
Signed informed consent with an understanding that patients can withdraw anytime.

Who cannot join

Inability to tolerate oral chemotherapy.
Primary gastric lesion confined to the mucosa or submucosa with isolated ovarian metastasis.
Central nervous system metastasis and/or carcinomatous meningitis.
Allergy to any components of the study medication.
History of previous malignancies or concurrent other malignancies, with the exception of completely resected basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, and other tumors with no recurrence for at least 5 years.
Uncontrolled pleural effusion, pericardial effusion, or ascites.

Show all 20Show fewer

Weight loss ≥20% within two months before enrollment.
Upper gastrointestinal obstruction or physiological dysfunction.
Previous cytotoxic chemotherapy, radiotherapy, immunotherapy, or curative surgery.
Prior PD-1/PD-L1/PD-L2 or other T-cell-targeting therapy.
Systemic steroid or immunosuppressant use within 14 days before enrollment.
Live vaccine within four weeks prior to enrollment.
Uncontrolled systemic disease.
Active or past autoimmune diseases that may recur.
Severe chronic infections or active infections requiring systemic antibacterial, antifungal, or antiviral treatment.
History of lung disease.
Pregnancy, lactation, or planning for pregnancy.
HBsAg-positive with HBV DNA ≥500 IU/mL.
Positive HIV antibody.
Conditions that may impact study compliance or participation.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xuefei Wang, MD, PhD contact

wang.xuefei@zs-hospital.sh.cn

China2 sites, 2 recruiting

Zhongshan Hospital Fudan University
Shanghai, Shanghai City, 200032
Xuefei Wang, MD, PhD, 0, wang.xuefei@zs-hospital.sh.cn
Xuefei Wang, MD, PhD
Not yet recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 201000
Xuefei Wang, 021-64041990, wang.xuefei@zs-hospital.sh.cn
Recruiting

Other trials in China

About this study

Official title: Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric or Gastroesophageal Adenocarcinoma (ROSETTE Trial): an Open-label, Single-center, Randomized Phase 2 Trial

ROSETTE trial is an open-label, randomized phase II study designed to investigate treatment strategies for patients with limited metastatic gastric or gastroesophageal adenocarcinoma. Eligible patients are randomized to receive either systemic treatment followed by surgeon-led local treatment, or systemic treatment alone. Systemic treatment combines immunotherapy with chemotherapy, with or without targeted therapy, while the surgeon-led local treatment utilizes a surgery-centric, multi-modality approach involving resection of both primary and metastatic tumors where feasible. For unresected or unresectable metastatic lesions, alternative local therapies are provided. The primary endpoint is the 1-year event-free survival (EFS) rate. Secondary endpoints include objective response rate (ORR), disease control rate (DCR), extended EFS, overall survival (OS), pathologic complete response rate (pCR), major pathologic response rate (MPR), and R0 resection rate.

Conditions: Gastric Cancer, GastroEsophageal Cancer
Being tested: Local treatment (Surgical), PD-1 Monoclonal Antibody, XELOX/SOX Chemotherapy Regimen, Local Treatment (Non-surgical), Trastuzumab
Keywords: Limited metastasis, Surgery, Local treatment, Gastric cancer, Perioperative treatment
Medical subject headings: Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Local treatment (Surgical)Procedure or surgery
Radical gastrectomy with standard D2 lymphadenectomy will be performed, along with radical surgery for resectable metastatic lesions.
PD-1 Monoclonal AntibodyDrug
PD-1 monoclonal antibody will be administered at a dosage of 200 mg via intravenous infusion (or according to the prescribing information of specific drug), once every cycle, each cycle spanning three weeks. The specific PD-1 antibody used will be determined by the investigators based on clinical considerations. Potential options include Sintilimab, Tislelizumab, or other approved PD-1 antibody products indicated for the treatment of metastatic gastric or gastroesophageal adenocarcinoma.
XELOX/SOX Chemotherapy RegimenDrug
Oxaliplatin: 130 mg/m² administered via a 3-hour intravenous infusion on D1 of each 3-week cycle.
Capecitabine: 1000 mg/m² taken orally twice daily. The first dose is administered on the evening of D1, and the last dose on the morning of D15, consisting of 2 weeks of treatment and a 1-week break in each 3-week cycle.
S-1: 40 mg/m² taken orally twice daily. The first dose is administered on the evening of D1, and the last dose on the morning of D15, consisting of 2 weeks of treatment and a 1-week break in each 3-week cycle.
During the maintainance phase, only capecitabine/S-1 will be administered.
Local Treatment (Non-surgical)Procedure or surgery
Additional local treatment for unresected metastatic lesions during phase 2 systemic therapy is permitted, including:
- Bone metastasis, distant lymph nodes, adrenal metastasis: Radiation therapy.
- Lung and liver metastasis: Radiofrequency ablation, interventional embolization, or radiation therapy.
- Peritoneal metastasis: Hyperthermic intraperitoneal chemotherapy (HIPEC).
- Other metastatic lesions: Non-surgical treatment options discussed by the multidisciplinary team.
TrastuzumabDrug
For HER2-positive patients, the dosing regimen for the addition of trastuzumab is as follows:
During the combination phase with XELOX/SOX chemotherapy: 8 mg/kg administered as an intravenous infusion on D1.
During the maintenance phase with capecitabine/S-1: 6 mg/kg administered as an intravenous infusion on D1.
This is repeated once every 3 weeks.
ZolbetuximabDrug
For patients with Claudin18.2-positive expression (IHC 2-3+ in ≥75% of tumor cells), Zolbetuximab may be added with the following dosing regimen:
First cycle: 800 mg/m² administered as an intravenous infusion on D1. Subsequent cycles: 600 mg/m² administered as an intravenous infusion on D1. This is repeated once every 3 weeks.

Study groups in NCT06468280
Study group	Role	What they receive
Local Treatment Arm (Arm A)	Experimental	In Phase 1, patients will receive four cycles of PD-1 antibody in combination with chemotherapy, with or without targeted therapy. Following this phase, a radiologic assessment will evaluate disease progression status. Patients identified as not experiencing progression will proceed with the study treatments. Subsequently, they will undergo surgeon-led local treatment, which may include standard D2 gastrectomy and metastasectomy when feasible. Non-surgical local treatments may also be administered to address unresected or unresectable metastatic lesions, either concurrently or sequentially with surgery. After surgical intervention, patients will receive up to four additional cycles of treatment, followed by maintenance therapy during Phase 2 of the systemic treatment. The total treatment duration may extend up to two years from the date of enrollment. Receives: Procedure: Local treatment (Surgical); Drug: PD-1 Monoclonal Antibody; Drug: XELOX/SOX Chemotherapy Regimen; Procedure: Local Treatment (Non-surgical); Drug: Trastuzumab; Drug: Zolbetuximab
Systemic Treatment Arm (Arm B)	Active comparator	In Phase 1, patients will receive four cycles of PD-1 antibody in conjunction with chemotherapy, with or without targeted therapy. Following this phase, a radiologic assessment will evaluate the disease progression status. Patients classified as not experiencing progression-defined as the absence of local progression, advancement of existing distant metastases, or the emergence of new distant metastatic lesions-will continue with the study treatments. In Phase 2, participants will receive an additional up to four cycles of treatment, followed by maintenance therapy. The total treatment duration could extend up to two years from the date of enrollment. Receives: Drug: PD-1 Monoclonal Antibody; Drug: XELOX/SOX Chemotherapy Regimen; Drug: Trastuzumab; Drug: Zolbetuximab

What is being measured

The primary outcome is the main question the study is designed to answer.

Event-Free Survival (EFS) Rate
Defined as the time from randomization to the first occurrence of any event, including disease progression (local progression, local recurrence, progression of existing distant metastatic lesions, or the emergence of new distant metastases) or death from any cause.
Measured: 1 year from the time of randomization

Secondary outcomes (7)

Objective Response Rate (ORR)
The proportion of subjects achieving complete response (CR) or partial response (PR) after completing phase I systemic treatment.
Measured: From randomization to the date of completing phase 1 systemic treatment, an average of 12 weeks.
Disease Control Rate (DCR)
The proportion of subjects achieving CR, PR, or stable disease (SD) after completing phase I systemic treatment.
Measured: From randomization to the date of completing phase 1 systemic treatment, an average of 12 weeks.
Pathological Complete Response (pCR) Rate
The proportion of surgical cohort subjects with no residual tumor cells and no positive lymph nodes (ypT0N0) in the primary tumor specimen. Non-surgical subjects in the surgical cohort are considered non-pCR.
Measured: From randomization to the date of surgery, an average of 14 weeks.
Major Pathologic Response Rate (MPR)
The proportion of surgical cohort subjects with residual tumor cells <10% in the primary tumor specimen based on the Becker tumor regression grading (TRG) standard (1a-1b). Non-surgical subjects in the surgical cohort are considered non-MPR.
Measured: From randomization to the date of surgery, an average of 14 weeks.
R0 Resection Rate
R0 resection is defined as no tumor at the gross or microscopic resection margins following standard D2 lymphadenectomy gastrectomy.
Measured: From randomization to the date of surgery, an average of 14 weeks.
Overall Survival (OS)
Time from randomization to death from any cause. Survivors are censored at the last known survival date.
Measured: Up to 5 years follow-up
Event-Free Survival (EFS)
Time from randomization to the first occurrence of disease progression (local recurrence, new distant metastasis, or progression of existing metastases) or death from any cause.
Measured: Up to 5 years follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Nov 2024Dec 2028

First posted21 Jun 2024
Study start8 Nov 2024
Primary completionDec 2027 (estimated)
Study completionDec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Gastric CancerStudies of the same condition, open and under way.
More trials run by Shanghai Zhongshan 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 84 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06468280
Sponsor's protocol ID: KY2024164
Acronym: ROSETTE
Status last verified: Jan 2026
First submitted: 28 May 2024
Last updated: 21 Jan 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Wu YY, Lee LC, Zeng H, Gu Y, Xu C, Chen WD, Shen ZB, Shen KT, Cui YH, Sun YH, Liu TS, Tang ZQ, Wang XF. Synergistic effects of PD-1 antibody and chemotherapy followed by surgery-centric local treatment in patients with limited-metastatic gastric or gastroesophageal adenocarcinoma (ROSETTE trial): an open-label, single-center, randomized phase 2 trial. BMC Cancer. 2025 Jun 1;25(1):981. doi: 10.1186/s12885-025-14331-5.
PubMed 40452026

Study at a glance

From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Synergistic Effects of PD-1 Antibody and Chemotherapy/Targeted Therapy Followed by Surgery-centric Local Treatment in Patients With Limited-metastatic Gastric or Gastroesophageal Adenocarcinoma (ROSETTE Trial): an Open-label, Single-center, Randomized Phase 2 Trial
ClinicalTrials.gov ID: NCT06468280
Acronym / sponsor ID: ROSETTE / KY2024164
Conditions: Gastric Cancer, GastroEsophageal Cancer
Keywords: Limited metastasis, Surgery, Local treatment, Gastric cancer, Perioperative treatment
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 84 participants (estimated)
Lead sponsor: Shanghai Zhongshan HospitalUniversity, hospital or other
Study start: 8 Nov 2024 (actual)
Primary completion: Dec 2027 (estimated)
Study completion: Dec 2028 (estimated)
First posted: 21 Jun 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Local Treatment Arm (Arm A)	Experimental	Procedure: Local treatment (Surgical), Drug: PD-1 Monoclonal Antibody, Drug: XELOX/SOX Chemotherapy Regimen, Procedure: Local Treatment (Non-surgical), Drug: Trastuzumab, Drug: ZolbetuximabIn Phase 1, patients will receive four cycles of PD-1 antibody in combination with chemotherapy, with or without targeted therapy. Following this phase, a radiologic assessment will evaluate disease progression status. Patients identified as not experiencing progression will proceed with the study treatments. Subsequently, they will undergo surgeon-led local treatment, which may include standard D2 gastrectomy and metastasectomy when feasible. Non-surgical local treatments may also be administered to address unresected or unresectable metastatic lesions, either concurrently or sequentially with surgery. After surgical intervention, patients will receive up to four additional cycles of treatment, followed by maintenance therapy during Phase 2 of the systemic treatment. The total treatment duration may extend up to two years from the date of enrollment.
Systemic Treatment Arm (Arm B)	Active comparator	Drug: PD-1 Monoclonal Antibody, Drug: XELOX/SOX Chemotherapy Regimen, Drug: Trastuzumab, Drug: ZolbetuximabIn Phase 1, patients will receive four cycles of PD-1 antibody in conjunction with chemotherapy, with or without targeted therapy. Following this phase, a radiologic assessment will evaluate the disease progression status. Patients classified as not experiencing progression-defined as the absence of local progression, advancement of existing distant metastases, or the emergence of new distant metastatic lesions-will continue with the study treatments. In Phase 2, participants will receive an additional up to four cycles of treatment, followed by maintenance therapy. The total treatment duration could extend up to two years from the date of enrollment.

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Men or women aged 18-79.
Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (Siewert II or III only) with known PD-L1 expression status.
Gastric cancer with proficient mismatch repair (pMMR) or microsatellite stability (MSS) as determined by immunohistochemistry or NCI-recommended microsatellite markers.
Primary gastric cancer lesions are resectable, with limited distant metastases meeting the either of the following criteria: (1) condition (a) only; (2) any single condition from (b), with or without (a).
(b1) Localized peritoneal metastasis: P0CY1, P1a, or P1b, according to the Japanese Classification of Gastric Carcinoma (15th edition).

Key exclusion criteria (20 listed)

Inability to tolerate oral chemotherapy.
Primary gastric lesion confined to the mucosa or submucosa with isolated ovarian metastasis.
Central nervous system metastasis and/or carcinomatous meningitis.
Allergy to any components of the study medication.
History of previous malignancies or concurrent other malignancies, with the exception of completely resected basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, and other tumors with no recurrence for at least 5 years.

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
Local treatment (Surgical)Radical gastrectomy with standard D2 lymphadenectomy will be performed, along with radical surgery for resectable metastatic lesions.	Procedure or surgery	Local Treatment Arm (Arm A)
PD-1 Monoclonal AntibodyPD-1 monoclonal antibody will be administered at a dosage of 200 mg via intravenous infusion (or according to the prescribing information of specific drug), once every cycle, each cycle spanning three weeks. The specific PD-1 antibody used will be determined by the investigators based on clinical considerations. Potential options include Sintilimab, Tislelizumab, or other approved PD-1 antibody products indicated for the treatment of metastatic gastric or gastroesophageal adenocarcinoma.	Drug	Local Treatment Arm (Arm A), Systemic Treatment Arm (Arm B)
XELOX/SOX Chemotherapy RegimenOxaliplatin: 130 mg/m² administered via a 3-hour intravenous infusion on D1 of each 3-week cycle. Capecitabine: 1000 mg/m² taken orally twice daily. The first dose is administered on the evening of D1, and the last dose on the morning of D15, consisting of 2 weeks of treatment and a 1-week break in each 3-week cycle. S-1: 40 mg/m² taken orally twice daily. The first dose is administered on the evening of D1, and the last dose on the morning of D15, consisting of 2 weeks of treatment and a 1-week break in each 3-week cycle. During the maintainance phase, only capecitabine/S-1 will be administered.	Drug	Local Treatment Arm (Arm A), Systemic Treatment Arm (Arm B)
Local Treatment (Non-surgical)Additional local treatment for unresected metastatic lesions during phase 2 systemic therapy is permitted, including: * Bone metastasis, distant lymph nodes, adrenal metastasis: Radiation therapy. * Lung and liver metastasis: Radiofrequency ablation, interventional embolization, or radiation therapy. * Peritoneal metastasis: Hyperthermic intraperitoneal chemotherapy (HIPEC). * Other metastatic lesions: Non-surgical treatment options discussed by the multidisciplinary team.	Procedure or surgery	Local Treatment Arm (Arm A)
TrastuzumabFor HER2-positive patients, the dosing regimen for the addition of trastuzumab is as follows: During the combination phase with XELOX/SOX chemotherapy: 8 mg/kg administered as an intravenous infusion on D1. During the maintenance phase with capecitabine/S-1: 6 mg/kg administered as an intravenous infusion on D1. This is repeated once every 3 weeks.	Drug	Local Treatment Arm (Arm A), Systemic Treatment Arm (Arm B)
ZolbetuximabFor patients with Claudin18.2-positive expression (IHC 2-3+ in ≥75% of tumor cells), Zolbetuximab may be added with the following dosing regimen: First cycle: 800 mg/m² administered as an intravenous infusion on D1. Subsequent cycles: 600 mg/m² administered as an intravenous infusion on D1. This is repeated once every 3 weeks.	Drug	Local Treatment Arm (Arm A), Systemic Treatment Arm (Arm B)

Primary outcome

Event-Free Survival (EFS) Rate
Time frame: 1 year from the time of randomization
Defined as the time from randomization to the first occurrence of any event, including disease progression (local progression, local recurrence, progression of existing distant metastatic lesions, or the emergence of new distant metastases) or death from any cause.

7 secondary outcomes

Objective Response Rate (ORR)
Time frame: From randomization to the date of completing phase 1 systemic treatment, an average of 12 weeks.
Disease Control Rate (DCR)
Time frame: From randomization to the date of completing phase 1 systemic treatment, an average of 12 weeks.
Pathological Complete Response (pCR) Rate
Time frame: From randomization to the date of surgery, an average of 14 weeks.
Major Pathologic Response Rate (MPR)
Time frame: From randomization to the date of surgery, an average of 14 weeks.
R0 Resection Rate
Time frame: From randomization to the date of surgery, an average of 14 weeks.
Overall Survival (OS)
Time frame: Up to 5 years follow-up
Event-Free Survival (EFS)
Time frame: Up to 5 years follow-up

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 21 Jan 2026.
Derived from this study: PubMed 40452026Wu YY, Lee LC, Zeng H, Gu Y, Xu C, Chen WD, Shen ZB, Shen KT, Cui YH, Sun YH, Liu TS, Tang ZQ, Wang XF. Synergistic effects of PD-1 antibody and chemotherapy followed by surgery-centric local treatment in patients with limited-metastatic gastric or gastroesophageal adenocarcinoma (ROSETTE trial): an open-label, single-center, randomized phase 2 trial. BMC Cancer. 2025 Jun 1;25(1):981. doi: 10.1186/s12885-025-14331-5.
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.

Xuefei Wang, MD, PhD contact

wang.xuefei@zs-hospital.sh.cn

Xuefei Wang, MD, PhD principal investigator

Fudan University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 15 inclusion and 20 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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 Xuefei Wang, MD, PhD (0, wang.xuefei@zs-hospital.sh.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) Rate (time frame: 1 year from the time of randomization). 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 NCT06468280, which also lists 1 linked publication.

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 21 Jan 2026.