Advanced Esophageal Squamous Cell CarcinomaPhase 3NCT07446335
A Phase III Study of First-line Anlotinib Combined With Benmelstobart in Patients With Advanced Esophageal Squamous Cell Carcinoma
A Phase 3 study testing anlotinib combined with benmelstobart and Toripalimab Combined with Chemotherapy in people with Advanced Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
A Randomized, Open-Label, Parallel-Controlled, Multicenter Phase III Clinical Trial to Evaluate the Safety and Efficacy of Anlotinib Hydrochloride Combined with Benmelstobart versus Toripalimab Combined with Chemotherapy as First-Line Treatment for Advanced Esophageal Squamous Cell Carcinoma Harboring Specific Gene… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Esophageal Squamous Cell Carcinoma
- What is being tested?
- anlotinib combined with benmelstobart and Toripalimab Combined with Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 578 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Histologically or cytologically confirmed unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (excluding adenosquamous carcinoma); (2) No prior systemic therapy, or recurrence more than 6 months after completion of (neo)adjuvant therapy or definitive chemoradiotherapy; (3) Age: ≥18 years (calculated from the date of informed consent signature); ECOG PS score: 0-1; estimated life expectancy >3 months; (4) Presence of TP53 mutation or FAT1 mutation, and absence of NOTCH3 mutation; (5) At least one measurable lesion as confirmed by RECIST 1.1 criteria; measurable lesions should not have received prior local treatment such as radiotherapy (lesions within prior radiation fields may be selected as target lesions if progression is confirmed); (6) Adequate major organ function meeting the following criteria:
- Hemoglobin ≥90 g/L;
- Absolute neutrophil count (ANC) ≥1.5 × 10^9/L;
- Platelets ≥75 × 10^9/L;
- Total bilirubin ≤1.5 × upper limit of normal (ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN (≤5 × ULN if liver metastases present);
Show all 9Show fewer
- Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min;
- Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤1.5 × ULN (for patients not receiving anticoagulation);
- Thyroid-stimulating hormone (TSH) ≤ULN (if TSH abnormal, normal free T3 and free T4 are acceptable); (7) Women of childbearing potential must agree to use effective contraception during the study and for 6 months after study completion, with negative serum or urine pregnancy test within 7 days prior to enrollment; men must agree to use effective contraception during the study and for 6 months after study completion, see Section 5.4 for details; (8) Voluntary participation in this study with signed informed consent and good compliance.
Who cannot join
- (1) Other malignancies within 3 years prior to first dose or currently concurrent malignancies, except:Other malignancies treated with surgery alone with continuous disease-free survival (DFS) of ≥5 years;Cured cervical carcinoma in situ, non-melanomatous skin cancer, and superficial bladder tumors [Ta (non-invasive), Tis (carcinoma in situ), and T1 (tumor invades lamina propria)]; (2) Conditions affecting intravenous injection or blood collection, or factors affecting oral drug administration (e.g., inability to swallow, chronic diarrhea, intestinal obstruction); (3) Prior treatment-related adverse events not resolved to ≤Grade 1 per CTCAE v5.0, except Grade 2 alopecia, Grade 2 peripheral neuropathy, Grade 2 anemia, clinically non-significant and asymptomatic laboratory abnormalities, and hypothyroidism stable on hormone replacement therapy judged by investigator as having no safety risk; (4) Major surgery, significant traumatic injury within 4 weeks prior to first dose, or anticipated need for major surgery during study treatment (except protocol-required surgery), or presence of non-healing wounds or fractures. [Major surgery defined as Grade 3 or higher per National Surgical Classification Directory 2022]; (5) Esophageal squamous cell carcinoma with active bleeding from primary lesion within 2 months; hematemesis or melena with daily blood loss ≥2.5 mL within 3 months prior to screening, or any bleeding event ≥CTCAE Grade 3, or any bleeding signs or history regardless of severity judged by investigator as unsuitable for enrollment; (6) Arterial or venous thrombotic events within 6 months prior to first dose, including cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism; (7) Active viral hepatitis with inadequate control. Eligible if: HBsAg-positive subjects: HBV DNA <2000 IU/mL (or 1×10⁴ copies/mL) or receiving anti-HBV treatment for ≥1 week prior to study with ≥1 log reduction in viral load, with willingness to continue anti-HBV therapy throughout study; HCV-infected subjects (HCV Ab or HCV RNA positive): judged by investigator as stable or receiving approved antiviral treatment at enrollment with plan to continue; (8) Active syphilis infection requiring treatment; (9) Active tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, radiation pneumonitis requiring treatment, or symptomatic active pneumonia; (10) History of psychoactive substance abuse with inability to abstain, or psychiatric disorder; (11) Prior or planned allogeneic bone marrow or solid organ transplantation; (12) History of hepatic encephalopathy; (13) Significant cardiovascular disease, including any of the following:
- New York Heart Association (NYHA) Class II or greater heart failure or left ventricular ejection fraction (LVEF) <50% by echocardiography;
- History of clinically significant ventricular arrhythmia (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or arrhythmia requiring continuous antiarrhythmic medication;
- Unstable angina pectoris;
- Myocardial infarction within 12 months;
- Fridericia-corrected QT interval (QTcF) >450 msec for males or >470 msec for females (if abnormal, three consecutive measurements ≥2 minutes apart, use average);
Show all 17Show fewer
- Congenital long QT syndrome or family history;
- History of deep vein thrombosis, pulmonary embolism, or other serious thromboembolism within 3 months prior to randomization (implanted port or catheter-related thrombosis, or superficial venous thrombosis not considered "serious");
- Current use or recent use (within 7 days prior to study treatment) of aspirin (>325 mg/day), dipyridamole, ticlopidine, clopidogrel, or cilostazol; (14) Active or uncontrolled severe infection (≥CTCAE Grade 2); (15) Renal failure requiring hemodialysis or peritoneal dialysis; (16) History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency disorders; (17) Use of immunosuppressants or systemic or absorbable topical corticosteroids for immunosuppressive purposes within 7 days prior to first dose (except prednisone ≤10 mg daily or equivalent); (18) Epilepsy requiring treatment; (19) Tumor-related symptoms and treatment:
- <!-- -->
- Cytotoxic chemotherapy, immunotherapy within 3 weeks, or radiotherapy or small molecule targeted therapy within 2 weeks prior to first dose, or within 5 half-lives of drug (whichever is shorter) from last treatment; (prior radiotherapy: target lesions should not be within radiation field, or if within field, progression must be confirmed);
- Traditional Chinese medicines with anti-tumor indications approved by NMPA within 2 weeks prior to first dose (including Compound Cantharis Capsules, Kang'ai Injection, Kanglaite Capsules/Injection, Aidi Injection, Brucea Javanica Oil Injection/Capsules, Xiaoaiping Tablets/Injection, Huachansu Capsules, etc.);
- Imaging evidence of significant tumor invasion into adjacent organs (aorta or trachea) with increased risk of bleeding or fistula; ulcerative ESCC with increased bleeding risk due to proximity to vessels;
- Known complete esophageal obstruction requiring interventional relief;
- Post-esophageal or tracheal stent placement;
- Uncontrolled pleural effusion, pericardial effusion, or moderate to severe ascites requiring repeated drainage (investigator judgment);
- Known spinal cord compression, carcinomatous meningitis, or brain metastasis with symptoms or symptom control <4 weeks; (20) Known hypersensitivity to study drug excipients; (21) Prior treatment with anlotinib hydrochloride or other anti-angiogenic agents, or any anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody; (22) Participation in other interventional clinical trials with investigational drug use within 4 weeks prior to first dose; (23) Pregnancy, lactation, or planned pregnancy during study period; (24) Any condition that, in the opinion of the investigator, would pose significant safety risk to the subject or interfere with completion of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: A Randomized, Open-Label, Parallel-Controlled, Multicenter Phase III Clinical Trial to Evaluate the Safety and Efficacy of Anlotinib Hydrochloride Combined With Benmelstobart Versus Toripalimab Combined With Chemotherapy as First-Line Treatment for Advanced Esophageal Squamous Cell Carcinoma Harboring Specific Gene Mutations
A Randomized, Open-Label, Parallel-Controlled, Multicenter Phase III Clinical Trial to Evaluate the Safety and Efficacy of Anlotinib Hydrochloride Combined with Benmelstobart versus Toripalimab Combined with Chemotherapy as First-Line Treatment for Advanced Esophageal Squamous Cell Carcinoma Harboring Specific Gene Mutations
- Being tested
- anlotinib combined with benmelstobart, Toripalimab Combined with Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anlotinib combined with benmelstobartDrug
Benmelstobart injection 1200 mg will be diluted in 250 mL normal saline (0.9% sodium chloride) and administered via intravenous infusion over 60 ± 10 minutes on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or a maximum of 24 months.
Anlotinib hydrochloride capsules 12 mg will be administered orally once daily before breakfast at approximately the same time each day on a schedule of 2 weeks on and 1 week off in 21-day cycles until disease progression or unacceptable toxicity.
Toripalimab Combined with ChemotherapyDrug
Induction Phase (maximum 6 cycles):Toripalimab injection 240 mg will be administered intravenously over 60 minutes on Day 1 of each 21-day cycle after dilution in 100 mL normal saline (0.9% sodium chloride). Chemotherapy regimen will be determined prior to randomization based on individual patient characteristics. Patients will receive one of the following chemotherapy regimens per local treatment standards: Cisplatin 60-75 mg/m² intravenously on Day 1 plus paclitaxel 150-175 mg/m² intravenously over >3 hours, both administered every 3 weeks; or cisplatin 60-75 mg/m² intravenously on Day 1 plus fluorouracil 700-850 mg/m² daily by continuous intravenous infusion over 24 hours on Days 1-5, repeated every 3 weeks.
Maintenance Phase :Toripalimab injection 240 mg will be administered intravenously over 60 minutes on Day 1 of each 21-day cycle after dilution in 100 mL normal saline (0.9% sodium chloride).
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib Hydrochloride Combined with Benmelstobart | Experimental | Not described Receives: Drug: anlotinib combined with benmelstobart |
| Toripalimab in Combination with Chemotherapy | Active comparator | Not described Receives: Drug: Toripalimab Combined with Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
The time from randomization to the first occurrence of disease progression or death due to any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1.
Measured: about 2 years
OS
The time from randomization to death due to any cause.
Measured: about 2 years
Secondary outcomes (4)
ORR
The percentage of subjects with complete response (CR) or partial response (PR) as determined by the investigator according to RECIST 1.1.
Measured: about 2 years
DCR
The percentage of subjects with complete response (CR), partial response (PR), or disease stabilization (SD) for ≥6 weeks as determined by the investigator according to RECIST 1.1.
Measured: about 2 years
DOR
The time from the first documented confirmed objective response to disease progression or death due to any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1.
Measured: about 2 years
AE
The incidence and severity of adverse events, with severity graded according to the NCI CTCAE v5.0 scale.
Measured: about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Esophageal Squamous Cell CarcinomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 578 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Wang, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446335
- Sponsor's protocol ID
- TQB2450-ALTN-Ⅲ-03
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel-Controlled, Multicenter Phase III Clinical Trial to Evaluate the Safety and Efficacy of Anlotinib Hydrochloride Combined With Benmelstobart Versus Toripalimab Combined With Chemotherapy as First-Line Treatment for Advanced Esophageal Squamous Cell Carcinoma Harboring Specific Gene Mutations
- ClinicalTrials.gov ID
- NCT07446335
- Acronym / sponsor ID
- TQB2450-ALTN-Ⅲ-03
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 578 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomized, Open-Label, Parallel-Controlled, Multicenter Phase III Clinical Trial to Evaluate the Safety and Efficacy of Anlotinib Hydrochloride Combined with Benmelstobart versus Toripalimab Combined with Chemotherapy as First-Line Treatment for Advanced Esophageal Squamous Cell Carcinoma Harboring Specific Gene Mutations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib Hydrochloride Combined with Benmelstobart | Experimental | Drug: anlotinib combined with benmelstobart |
| Toripalimab in Combination with Chemotherapy | Active comparator | Drug: Toripalimab Combined with Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- (1) Histologically or cytologically confirmed unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (excluding adenosquamous carcinoma); (2) No prior systemic therapy, or recurrence more than 6 months after completion of (neo)adjuvant therapy or definitive chemoradiotherapy; (3) Age: ≥18 years (calculated from the date of informed consent signature); ECOG PS score: 0-1; estimated life expectancy >3 months; (4) Presence of TP53 mutation or FAT1 mutation, and absence of NOTCH3 mutation; (5) At least one measurable lesion as confirmed by RECIST 1.1 criteria; measurable lesions should not have received prior local treatment such as radiotherapy (lesions within prior radiation fields may be selected as target lesions if progression is confirmed); (6) Adequate major organ function meeting the following criteria:
- Hemoglobin ≥90 g/L;
- Absolute neutrophil count (ANC) ≥1.5 × 10^9/L;
- Platelets ≥75 × 10^9/L;
- Total bilirubin ≤1.5 × upper limit of normal (ULN);
Key exclusion criteria (17 listed)
- (1) Other malignancies within 3 years prior to first dose or currently concurrent malignancies, except:Other malignancies treated with surgery alone with continuous disease-free survival (DFS) of ≥5 years;Cured cervical carcinoma in situ, non-melanomatous skin cancer, and superficial bladder tumors [Ta (non-invasive), Tis (carcinoma in situ), and T1 (tumor invades lamina propria)]; (2) Conditions affecting intravenous injection or blood collection, or factors affecting oral drug administration (e.g., inability to swallow, chronic diarrhea, intestinal obstruction); (3) Prior treatment-related adverse events not resolved to ≤Grade 1 per CTCAE v5.0, except Grade 2 alopecia, Grade 2 peripheral neuropathy, Grade 2 anemia, clinically non-significant and asymptomatic laboratory abnormalities, and hypothyroidism stable on hormone replacement therapy judged by investigator as having no safety risk; (4) Major surgery, significant traumatic injury within 4 weeks prior to first dose, or anticipated need for major surgery during study treatment (except protocol-required surgery), or presence of non-healing wounds or fractures. [Major surgery defined as Grade 3 or higher per National Surgical Classification Directory 2022]; (5) Esophageal squamous cell carcinoma with active bleeding from primary lesion within 2 months; hematemesis or melena with daily blood loss ≥2.5 mL within 3 months prior to screening, or any bleeding event ≥CTCAE Grade 3, or any bleeding signs or history regardless of severity judged by investigator as unsuitable for enrollment; (6) Arterial or venous thrombotic events within 6 months prior to first dose, including cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism; (7) Active viral hepatitis with inadequate control. Eligible if: HBsAg-positive subjects: HBV DNA <2000 IU/mL (or 1×10⁴ copies/mL) or receiving anti-HBV treatment for ≥1 week prior to study with ≥1 log reduction in viral load, with willingness to continue anti-HBV therapy throughout study; HCV-infected subjects (HCV Ab or HCV RNA positive): judged by investigator as stable or receiving approved antiviral treatment at enrollment with plan to continue; (8) Active syphilis infection requiring treatment; (9) Active tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, radiation pneumonitis requiring treatment, or symptomatic active pneumonia; (10) History of psychoactive substance abuse with inability to abstain, or psychiatric disorder; (11) Prior or planned allogeneic bone marrow or solid organ transplantation; (12) History of hepatic encephalopathy; (13) Significant cardiovascular disease, including any of the following:
- <!-- -->
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 |
|---|---|---|
| anlotinib combined with benmelstobartBenmelstobart injection 1200 mg will be diluted in 250 mL normal saline (0.9% sodium chloride) and administered via intravenous infusion over 60 ± 10 minutes on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or a maximum of 24 months. Anlotinib hydrochloride capsules 12 mg will be administered orally once daily before breakfast at approximately the same time each day on a schedule of 2 weeks on and 1 week off in 21-day cycles until disease progression or unacceptable toxicity. | Drug | Anlotinib Hydrochloride Combined with Benmelstobart |
| Toripalimab Combined with ChemotherapyInduction Phase (maximum 6 cycles):Toripalimab injection 240 mg will be administered intravenously over 60 minutes on Day 1 of each 21-day cycle after dilution in 100 mL normal saline (0.9% sodium chloride). Chemotherapy regimen will be determined prior to randomization based on individual patient characteristics. Patients will receive one of the following chemotherapy regimens per local treatment standards: Cisplatin 60-75 mg/m² intravenously on Day 1 plus paclitaxel 150-175 mg/m² intravenously over >3 hours, both administered every 3 weeks; or cisplatin 60-75 mg/m² intravenously on Day 1 plus fluorouracil 700-850 mg/m² daily by continuous intravenous infusion over 24 hours on Days 1-5, repeated every 3 weeks. Maintenance Phase :Toripalimab injection 240 mg will be administered intravenously over 60 minutes on Day 1 of each 21-day cycle after dilution in 100 mL normal saline (0.9% sodium chloride). | Drug | Toripalimab in Combination with Chemotherapy |
Primary outcome
PFS
Time frame: about 2 years
The time from randomization to the first occurrence of disease progression or death due to any cause, whichever occurs first, as determined by the investigator according to RECIST v1.1.
OS
Time frame: about 2 years
The time from randomization to death due to any cause.
4 secondary outcomes
ORR
Time frame: about 2 years
DCR
Time frame: about 2 years
DOR
Time frame: about 2 years
AE
Time frame: about 2 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 3 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Advanced Esophageal Squamous Cell Carcinoma
RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
RecruitingPhase 2
A Study Investigating Alternate Schedules of Tislelizumab Plus Chemotherapy in Japanese Patients With First-line Advanced ESCC
Advanced Esophageal Squamous Cell Carcinoma, Metastatic Esophageal Squamous Cell Carcinoma
RecruitingPhase 1/2
A Study of ASP388B Given by Itself and With Standard Therapies in Participants With Solid Tumors
Locally Advanced or Metastatic Solid Tumors
RecruitingPhase 3
A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01)
Esophageal Squamous Cell Carcinoma
RecruitingPhase 2
Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC
Esophageal Squamous Cell Carcinoma
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 3 study testing anlotinib combined with benmelstobart and Toripalimab Combined with Chemotherapy in people with Advanced Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou 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 9 inclusion and 17 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 3 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact feng wang (0086-13938244776, fengw010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: about 2 years). The study lists 2 primary outcomes in all. 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 3 Mar 2026.