Colorectal CarcinomaPhase 2NCT06850103
SCRT-CAPEOX-Serplulimab for MSS/pMMR Rectal Cancer With Oligometastases
A Phase 2 study testing short-course radiotherapy, CAPEOX/XELOX and Serplulimab in people with Colorectal Carcinoma and Oligometastases, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Background and Significance: Colorectal cancer (CRC) ranks as the third most common cancer and the second leading cause of cancer-related deaths globally. Despite improved early screening rates, a significant proportion of newly diagnosed CRC patients present with synchronous metastases, predominantly liver… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Carcinoma, Oligometastases, pMMR
- What is being tested?
- short-course radiotherapy, CAPEOX/XELOX and Serplulimab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2025to Dec 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has signed the written Informed Consent Form (ICF) and is able to comply with protocol-specified visits and procedures.
- Age between 18-75 years.
- Histologically confirmed primary rectal adenocarcinoma, with MRI showing tumor location within 10cm from the anal verge.
- Synchronous oligometastatic rectal cancer confirmed by comprehensive imaging evaluation (contrast-enhanced CT, contrast-enhanced MRI, PET-CT, etc.), with ≤2 metastatic sites and ≤5 total metastatic lesions.
- Microsatellite stability status confirmed as MSS (using the NCI-recommended 5 microsatellite markers: BAT25, BAT26, D5S346, D2S123, D17S250) or proficient mismatch repair (pMMR) status confirmed by immunohistochemistry showing positive nuclear expression of all 4 MMR proteins (MLH1, MSH2, MSH6, PMS2).
- At least one measurable lesion according to RECIST v1.1 criteria.
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- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.
- Adequate organ function and bone marrow reserve, defined as follows:
- Complete blood count:
- Absolute Neutrophil Count (ANC) ≥1.5×109/L Platelet count (PLT) ≥100×109/L Hemoglobin (HGB) ≥10.0g/dL
- Liver function:
- Total Bilirubin (TBIL) ≤1.5×Upper Limit of Normal (ULN) Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤3×ULN Serum albumin (ALB) ≥35 g/L
- Renal function:
- Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min (calculated using Cockcroft-Gault formula [see Appendix 3] or standard 24-hour urine collection method) Urine protein by dipstick <2+ For subjects with baseline urine protein ≥2+ by dipstick, 24-hour urine protein must be <1g
- Coagulation:
- International Normalized Ratio (INR) ≤1.5 Activated partial thromboplastin time (APTT) ≤1.5×ULN Certain anticoagulant medications (such as antiplatelet agents, vitamin K antagonists) must be discontinued 7-14 days before surgery and replaced with alternative medications (such as low molecular weight heparin) No concurrent serious diseases that would threaten subject survival (leading to expected survival <5 years).
- Women of childbearing potential and men whose partners are of childbearing potential must use effective contraception during the entire treatment period and for 6 months after treatment completion. Female subjects must either have evidence of post-menopausal status, or if pre-menopausal, have a negative urine or serum pregnancy test.
Who cannot join
- More than 2 metastatic sites or more than 5 total metastatic lesions confirmed by imaging evaluation.
- Prior anti-tumor therapy for the study disease, including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other drugs targeting T-cell co-stimulation or immune checkpoint pathways (e.g., OX40, CD137), or adoptive cell immunotherapy.
- Concurrent participation in another clinical trial, except for observational (non-interventional) studies or survival follow-up phase of interventional studies.
- Receipt of any investigational drug within 4 weeks prior to first dose of study drug.
- History of blood transfusion or use of G-CSF, GM-CSF, EPO, TPO, or IL-11 within 14 days prior to screening laboratory tests.
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- Use of immunosuppressive medications within 4 weeks prior to first dose of study drug, excluding:
- Intranasal inhaled corticosteroids or local steroid injections Systemic corticosteroids at ≤10 mg/day prednisone equivalent Corticosteroids as premedication for allergic reactions (e.g., CT contrast) Traditional Chinese medicines with anti-tumor indications or immunomodulatory effects within 1 week prior to first dose Receipt of live or attenuated vaccines within 4 weeks prior to first dose or anticipated during the study period.
- Major surgery within 4 weeks prior to first dose (e.g., craniotomy, thoracotomy, or laparotomy), anticipated major surgery during treatment (excluding protocol-specified rectal cancer surgery), or presence of unhealed wounds, ulcers, or fractures.
- Known active or suspected autoimmune disease or history within past 2 years (exceptions: eczema, vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic treatment in past 2 years; hypothyroidism requiring only hormone replacement; Type I diabetes requiring only insulin).
- Known history of primary immunodeficiency.
- Active tuberculosis, current anti-TB treatment, or anti-TB treatment within 1 year prior to first dose.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Known allergy to capecitabine, oxaliplatin, serplulimab, or other monoclonal antibody components.
- Clinically significant ascites, pleural effusion requiring intervention, or symptomatic pericardial effusion requiring drainage.
- HIV infection (HIV antibody positive).
- Acute or chronic active hepatitis B (defined as HBsAg positive or HBcAb positive only with HBV DNA ≥2000 IU/mL or ≥1×104 copies/mL) or hepatitis C (defined as HCV antibody positive with detectable HCV RNA).
- Active syphilis infection requiring treatment.
- Severe infection within 4 weeks prior to first dose, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia; therapeutic oral or IV antibiotics within two weeks prior to first dose.
- Symptomatic congestive heart failure (NYHA class II-IV) or LVEF <50%; symptomatic or uncontrolled arrhythmias; congenital long QT syndrome or QTc >500 ms at screening (Fridericia's formula).
- Uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg) despite standard therapy, history of hypertensive crisis or encephalopathy.
- Severe bleeding diathesis or coagulation disorders, or current thrombolytic therapy.
- Any arterial thromboembolic events within 6 months prior to first dose, including myocardial infarction, unstable angina, stroke, or TIA.
- Esophageal or gastric varices requiring immediate intervention; high bleeding risk subjects require endoscopic evaluation within 3 months before enrollment.
- History of GI perforation and/or fistula within 6 months prior to first dose.
- Life-threatening bleeding event within 3 months prior to first dose, or Grade 3/4 GI/variceal bleeding requiring transfusion, endoscopy, or surgery.
- History of DVT, PE, or other serious thromboembolism within 3 months prior to first dose (excluding catheter-related thrombosis or superficial thrombosis).
- Uncontrolled metabolic disorders or other non-malignant conditions causing high medical risk or uncertain survival evaluation.
- Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh B >7 or worse cirrhosis.
- Bowel obstruction (including incomplete requiring parenteral nutrition); conditions with perforation risk; history of extensive bowel resection, Crohn's disease, ulcerative colitis, or chronic diarrhea.
- Interstitial lung disease requiring treatment; history of pulmonary fibrosis, pneumoconiosis, drug-induced pneumonitis, organizing pneumonia, or severe pulmonary dysfunction.
- Significant malnutrition (5% weight loss within 1 month or 15% within 3 months of consent, or >50% reduced intake for 1 week), unless corrected for ≥4 weeks before first dose.
- History of other primary malignancies, except:
- Cured malignancies with ≥2 years disease-free and low recurrence risk Well-treated non-melanoma skin cancer or lentigo maligna Well-treated carcinoma in situ
- Other acute or chronic conditions that could:
- Increase study participation risks Interfere with result interpretation Make subject unsuitable per investigator judgment Neurological, psychiatric, or social conditions affecting compliance or safety assessment.
- Alcohol, drug, or substance abuse affecting drug administration or toxicity analysis.
- Pregnant or breastfeeding women.
- Conditions interfering with medication management or toxicity analysis due to alcohol, drug, or substance use.
- Pregnancy or breastfeeding.
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
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Jiang Weiqin, M.D., +8615068117618, weiqinjiang@zju.edu.cn
About this study
Official title: A Phase II Exploratory Multicenter Randomized Controlled Clinical Trial to Evaluate the Effectiveness of Neoadjuvant Short-Course Radiotherapy (SCRT) Followed by CAPEOX Chemotherapy and Serplulimab in Microsatellite Stable (MSS) or Proficient Mismatch Repair (pMMR) Rectal Cancer With Synchronous Oligometastases
Background and Significance:
Colorectal cancer (CRC) ranks as the third most common cancer and the second leading cause of cancer-related deaths globally. Despite improved early screening rates, a significant proportion of newly diagnosed CRC patients present with synchronous metastases, predominantly liver metastases. The concept of oligometastases, introduced by Hellman and Weichselbaum in 1995, describes a transitional state between localized disease and widespread metastases, characterized by limited metastatic lesions (typically 1-5) confined to 1-2 organs.
Read more
Current Treatment Landscape:
The management of oligometastatic disease combines local therapeutic approaches (surgery, radiotherapy, radiofrequency ablation) with systemic treatments, aiming to achieve No Evidence of Disease (NED) status. The ESMO guidelines officially categorized metastatic CRC into oligometastatic and widespread metastatic states in 2016, emphasizing the importance of integrated local and systemic treatments for oligometastatic colorectal liver metastases (CRLM).
Treatment Evolution and Challenges:
While the EPOC study established CAPEOX neoadjuvant chemotherapy followed by R0 resection as the standard treatment for initially resectable CRLM, patients with synchronous rectal cancer oligometastases present unique challenges due to complex local anatomy and high local recurrence risks. Although various neoadjuvant approaches, including Total Neoadjuvant Therapy (TNT), have been studied, they have not demonstrated significant long-term survival benefits, primarily because distant metastases impact survival more significantly than local recurrence.
Innovative Approach:
Recent success with Immunotherapy-Based Total Neoadjuvant Therapy (iTNT) in microsatellite stable/proficient mismatch repair (MSS/pMMR) locally advanced rectal cancer has shown promising results. Short-course radiotherapy (SCRT) combined with chemotherapy and immunotherapy has demonstrated superior efficacy trends, attributed to radiation's immune-activating effects on both local and distant tumor microenvironments.
Research Objective:
This project aims to evaluate the effectiveness of iTNT combined with SCRT in MSS/pMMR rectal cancer patients with synchronous oligometastases. The novel approach integrates SCRT with CAPEOX chemotherapy and Serplulimab, potentially improving complete response rates, organ preservation opportunities, and overall treatment efficacy while reducing recurrence risks. This pioneering study represents the first investigation of iTNT in synchronous rectal cancer oligometastases, offering a potentially transformative treatment strategy for this challenging patient population.
Research Innovation:
The study uniquely combines SCRT, CAPEOX chemotherapy, and Serplulimab in a neoadjuvant setting for MSS/pMMR synchronous rectal cancer oligometastases, addressing an unmet clinical need and potentially establishing a new treatment paradigm in this field.
- Conditions
- Colorectal Carcinoma, Oligometastases, pMMR, MSS, iTNT
- Being tested
- short-course radiotherapy, CAPEOX/XELOX, Serplulimab, surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short-course radiotherapyRadiation
Neoadjuvant short-course radiotherapy (SCRT) will be administered at a total dose of 25 Gy, delivered in 5 fractions of 5 Gy each.
CAPEOX/XELOXDrug
Capecitabine: 1000 mg/m² BID, D1-14, Q3W × 4 cycles Oxaliplatin: 130 mg/m² IV, D1, Q3W × 4 cycles
SerplulimabDrug
Serplulimab: 300 mg IV, D1, Q3W × 4 cycles
surgeryProcedure or surgery
Primary tumor: Total Mesorectal Excision (TME) Metastatic lesions: Local therapeutic intervention
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients in the experimental arm will receive short-course radiotherapy (SCRT) followed by 4 cycles of CAPEOX chemotherapy plus Serplulimab as neoadjuvant therapy, then undergo TME resection of the primary tumor and local treatment of metastatic lesions, followed by 4 additional cycles of CAPEOX plus Serplulimab as adjuvant therapy. Receives: Radiation: short-course radiotherapy; Drug: CAPEOX/XELOX; Drug: Serplulimab; Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year PFS
Measured: within 3 years from study enrollment.
Secondary outcomes (4)
No Evidence of Disease (NED) rate
Measured: Within 3 months after surgery
Primary tumor pathological complete response (pCR) rate
Measured: After surgery
3-year local recurrence rate (LRR)
Measured: within 3 years after primary treatment
5-year OS
Measured: within 5 years from study enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start22 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo No.2 Hospital, Ningbo Medical Center Lihuili Hospital, Second Affiliated Hospital of Wenzhou Medical University, Ningbo No. 1 Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Affiliated People's Hospital of Ningbo University
- Responsible party
- Principal investigator, Feng Ye, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850103
- Sponsor's protocol ID
- SCRT-CAP-Serp TriFire
- Status last verified
- Nov 2025
- First submitted
- 24 Feb 2025
- Last updated
- 25 Mar 2026
- Results posted
- 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 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Exploratory Multicenter Randomized Controlled Clinical Trial to Evaluate the Effectiveness of Neoadjuvant Short-Course Radiotherapy (SCRT) Followed by CAPEOX Chemotherapy and Serplulimab in Microsatellite Stable (MSS) or Proficient Mismatch Repair (pMMR) Rectal Cancer With Synchronous Oligometastases
- ClinicalTrials.gov ID
- NCT06850103
- Acronym / sponsor ID
- SCRT-CAP-Serp TriFire
- Conditions
- Colorectal Carcinoma, Oligometastases, pMMR, MSS, iTNT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Ningbo No.2 Hospital, Ningbo Medical Center Lihuili Hospital, Second Affiliated Hospital of Wenzhou Medical University, Ningbo No. 1 Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Affiliated People's Hospital of Ningbo University
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 27 Feb 2025 (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.
Background and Significance:
Colorectal cancer (CRC) ranks as the third most common cancer and the second leading cause of cancer-related deaths globally. Despite improved early screening rates, a significant proportion of newly diagnosed CRC patients present with synchronous metastases, predominantly liver metastases. The concept of oligometastases, introduced by Hellman and Weichselbaum in 1995, describes a transitional state between localized disease and widespread metastases, characterized by limited metastatic lesions (typically 1-5) confined to 1-2 organs.
Current Treatment Landscape:
The management of oligometastatic disease combines local therapeutic approaches (surgery, radiotherapy, radiofrequency ablation) with systemic treatments, aiming to achieve No Evidence of Disease (NED) status. The ESMO guidelines officially categorized metastatic CRC into oligometastatic and widespread metastatic states in 2016, emphasizing the importance of integrated local and systemic treatments for oligometastatic colorectal liver metastases (CRLM).
Treatment Evolution and Challenges:
While the EPOC study established CAPEOX neoadjuvant chemotherapy followed by R0 resection as the standard treatment for initially resectable CRLM, patients with synchronous rectal cancer oligometastases present unique challenges due to complex local anatomy and high local recurrence risks. Although various neoadjuvant approaches, including Total Neoadjuvant Therapy (TNT), have been studied, they have not demonstrated significant long-term survival benefits, primarily because distant metastases impact survival more significantly than local recurrence.
Innovative Approach:
Recent success with Immunotherapy-Based Total Neoadjuvant Therapy (iTNT) in microsatellite stable/proficient mismatch repair (MSS/pMMR) locally advanced rectal cancer has shown promising results. Short-course radiotherapy (SCRT) combined with chemotherapy and immunotherapy has demonstrated superior efficacy trends, attributed to radiation's immune-activating effects on both local and distant tumor microenvironments.
Research Objective:
This project aims to evaluate the effectiveness of iTNT combined with SCRT in MSS/pMMR rectal cancer patients with synchronous oligometastases. The novel approach integrates SCRT with CAPEOX chemotherapy and Serplulimab, potentially improving complete response rates, organ preservation opportunities, and overall treatment efficacy while reducing recurrence risks. This pioneering study represents the first investigation of iTNT in synchronous rectal cancer oligometastases, offering a potentially transformative treatment strategy for this challenging patient population.
Research Innovation:
The study uniquely combines SCRT, CAPEOX chemotherapy, and Serplulimab in a neoadjuvant setting for MSS/pMMR synchronous rectal cancer oligometastases, addressing an unmet clinical need and potentially establishing a new treatment paradigm in this field.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Radiation: short-course radiotherapy, Drug: CAPEOX/XELOX, Drug: Serplulimab, Procedure: surgeryPatients in the experimental arm will receive short-course radiotherapy (SCRT) followed by 4 cycles of CAPEOX chemotherapy plus Serplulimab as neoadjuvant therapy, then undergo TME resection of the primary tumor and local treatment of metastatic lesions, followed by 4 additional cycles of CAPEOX plus Serplulimab as adjuvant therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Has signed the written Informed Consent Form (ICF) and is able to comply with protocol-specified visits and procedures.
- Age between 18-75 years.
- Histologically confirmed primary rectal adenocarcinoma, with MRI showing tumor location within 10cm from the anal verge.
- Synchronous oligometastatic rectal cancer confirmed by comprehensive imaging evaluation (contrast-enhanced CT, contrast-enhanced MRI, PET-CT, etc.), with ≤2 metastatic sites and ≤5 total metastatic lesions.
- Microsatellite stability status confirmed as MSS (using the NCI-recommended 5 microsatellite markers: BAT25, BAT26, D5S346, D2S123, D17S250) or proficient mismatch repair (pMMR) status confirmed by immunohistochemistry showing positive nuclear expression of all 4 MMR proteins (MLH1, MSH2, MSH6, PMS2).
Key exclusion criteria (40 listed)
- More than 2 metastatic sites or more than 5 total metastatic lesions confirmed by imaging evaluation.
- Prior anti-tumor therapy for the study disease, including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other drugs targeting T-cell co-stimulation or immune checkpoint pathways (e.g., OX40, CD137), or adoptive cell immunotherapy.
- Concurrent participation in another clinical trial, except for observational (non-interventional) studies or survival follow-up phase of interventional studies.
- Receipt of any investigational drug within 4 weeks prior to first dose of study drug.
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 |
|---|---|---|
| short-course radiotherapyNeoadjuvant short-course radiotherapy (SCRT) will be administered at a total dose of 25 Gy, delivered in 5 fractions of 5 Gy each. | Radiation | Experimental |
| CAPEOX/XELOXCapecitabine: 1000 mg/m² BID, D1-14, Q3W × 4 cycles Oxaliplatin: 130 mg/m² IV, D1, Q3W × 4 cycles | Drug | Experimental |
| SerplulimabSerplulimab: 300 mg IV, D1, Q3W × 4 cycles | Drug | Experimental |
| surgeryPrimary tumor: Total Mesorectal Excision (TME) Metastatic lesions: Local therapeutic intervention | Procedure or surgery | Experimental |
Primary outcome
3-year PFS
Time frame: within 3 years from study enrollment.
4 secondary outcomes
No Evidence of Disease (NED) rate
Time frame: Within 3 months after surgery
Primary tumor pathological complete response (pCR) rate
Time frame: After surgery
3-year local recurrence rate (LRR)
Time frame: within 3 years after primary treatment
5-year OS
Time frame: within 5 years from study enrollment.
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 25 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing short-course radiotherapy, CAPEOX/XELOX and Serplulimab in people with Colorectal Carcinoma and Oligometastases, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 40 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 25 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 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 Feng Ye (86-13858191208, yefeng-h1@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year PFS (time frame: within 3 years from study enrollment.). 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 25 Mar 2026.