Biliary Tract Cancer (BTC)Phase 2NCT07733115
QL1706（Iparomlimab/Tuvonralimab) Combined With Gemcitabine and Cisplatin as First-Line Treatment for PD-L1-Positive Biliary Tract Cancer
A Phase 2 study testing Iparomlimab and Tuvonralimab (QL1706) and Gemcitabine and Cisplatin Chemotherapy in people with Biliary Tract Cancer (BTC), run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate whether QL1706(Iparomlimab/Tuvonralimab) in combination with gemcitabine and cisplatin (GC) is effective and safe as a first-line treatment for patients with advanced biliary tract cancer whose tumors are PD-L1 positive (CPS ≥ 1). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Cancer (BTC)
- What is being tested?
- Iparomlimab and Tuvonralimab (QL1706) and Gemcitabine and Cisplatin Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2026to 31 Dec 2029
- 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
- Have signed the written informed consent form and be able to comply with all scheduled visits and study procedures specified in the protocol.
- Aged between 18 and 75 years old (inclusive), with no restriction on gender.
- Histologically confirmed unresectable or metastatic advanced biliary tract adenocarcinoma, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.
- PD-L1-positive tumor (Combined Positive Score [CPS] ≥ 1).
- Have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
- No prior systemic therapy (chemotherapy, targeted therapy, or immunotherapy). Patients who relapse more than 6 months after curative surgery, and if they have received adjuvant therapy (chemotherapy and/or radiotherapy), relapse more than 6 months after completion of adjuvant therapy, are eligible.
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- Life expectancy of at least 12 weeks.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
- Have adequate organ and bone marrow function. Laboratory test results obtained within 7 days prior to enrollment shall meet the following requirements. No blood products, erythropoietin, colony-stimulating factors, thrombopoietin, albumin or other parenteral corrective medications are allowed within 14 days before laboratory testing:
- Hematology: Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L; Platelet (PLT) count ≥ 100×10⁹/L; Hemoglobin (HGB) > 9 g/dL.
- Liver function: Total Bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal (ULN); Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN.
- Renal function: Creatinine clearance (calculated by the Cockcroft-Gault formula) ≥ 60 mL/min.
- Thyroid function: Thyroid-stimulating hormone (TSH) within normal range. If baseline TSH is outside normal range, patients are eligible if total T3 (or FT3) and FT4 are within normal limits.
- Cardiac enzymes: Within normal limits (isolated laboratory abnormalities deemed clinically insignificant by the investigator are allowed).
- Female participants of childbearing potential and male participants whose partners are of childbearing potential must agree to use effective contraception throughout the treatment period and for 6 months after the last study drug administration.
Who cannot join
- Histologically or cytologically confirmed diagnosis of tumors containing components other than biliary adenocarcinoma (e.g., neuroendocrine carcinoma, squamous cell carcinoma, or mixed histologies).
- Prior treatment with anti-PD-1/PD-L1 agents, anti-CTLA-4 agents, or other antitumor immunotherapies.
- Presence of unresolved Grade >1 toxicities related to any previous antitumor therapy (persistent Grade 2 alopecia, fatigue, or endocrine disorders well-controlled with hormone replacement therapy are excluded).
- History of other malignancies within 5 years prior to enrollment, except for radically cured basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ with no evidence of recurrence, or other malignancies with complete remission and no active disease for at least 2 years prior to enrollment.
- Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first drug administration. Replacement therapies (e.g., levothyroxine, insulin, physiological corticosteroids for adrenal or pituitary insufficiency) are not regarded as systemic treatment. Known primary immunodeficiency. Patients with positive autoantibodies only should be assessed by the investigator for the presence of autoimmune disease.
- Systemic corticosteroid therapy (excluding nasal, inhaled, or other topical corticosteroids) or any other form of immunosuppressive therapy within 4 weeks prior to first dose. Note: Physiologic doses of corticosteroids (≤ 10 mg/day of prednisone or equivalent) are permitted.
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- Clinically uncontrolled pleural effusion or ascites (patients who do not require drainage or have no significant increase in fluid for 3 days after drainage cessation may be enrolled).
- Known allogeneic organ transplant (except corneal transplant) or allogeneic hematopoietic stem cell transplant.
- Known allergy to any active ingredient or excipient of the study drugs.
- Presence of clinically significant cardiovascular and cerebrovascular diseases, including:
- Electrocardiogram abnormalities (e.g., complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmias, or atrial fibrillation) that are symptomatic and difficult to control.
- Unstable angina, congestive heart failure, or chronic heart failure of New York Heart Association (NYHA) Class ≥ 2.
- Any arterial thrombotic, embolic, or ischemic event (e.g., myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack) within 6 months prior to enrollment.
- Uncontrolled hypertension (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg).
- Major surgical procedure (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to first dose, or non-healing wounds, ulcers, or fractures.
- Active tuberculosis; patients currently receiving anti-tuberculosis treatment or those who received anti-tuberculosis therapy within 1 year before the first drug administration.
- Active or uncontrolled infection requiring systemic treatment.
- Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction.
- Poorly controlled diabetes (fasting blood glucose > 10 mmol/L).
- Urinalysis showing protein ≥ 2+ with 24-hour urine protein > 1.0 g.
- Confirmed HIV positivity or history of acquired immunodeficiency syndrome (AIDS).
- Untreated active hepatitis B (defined as HBsAg positive with HBV-DNA copy number > 2000 IU/mL); patients with HBV-DNA positive may be enrolled if levels show a declining trend.
- Active HCV infection (HCV antibody positive and HCV-RNA above the lower limit of detection).
- Vaccination with live attenuated vaccine within 4 weeks prior to first dose.
- Pregnant or breastfeeding females, or females planning to become pregnant before drug administration, during treatment or within 6 months after the last dose of study drug.
- Psychiatric disorders preventing treatment compliance.
- Any concomitant disease, prior treatment, abnormal laboratory findings, history of substance abuse or current substance use, which in the investigator's judgment may compromise patient safety, hinder informed consent acquisition, affect treatment compliance or interfere with the safety assessment of the study drug.
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
Zhongshan Hospital
Shanghai
Xiaoyong Huang, 086-15021519215, huang.xiaoyong@zs-hospital.sh.cn
About this study
Official title: A Multicenter, Single-Arm, Phase II Clinical Study of QL1706 in Combination With Gemcitabine and Cisplatin (GC) as First-Line Treatment for PD-L1-Positive Biliary Tract Cancer
The goal of this clinical trial is to evaluate whether QL1706(Iparomlimab/Tuvonralimab) in combination with gemcitabine and cisplatin (GC) is effective and safe as a first-line treatment for patients with advanced biliary tract cancer whose tumors are PD-L1 positive (CPS ≥ 1). This is a multicenter, single-arm, phase II clinical study. A total of 38 eligible patients will be enrolled .
The main questions it aims to answer are: what proportion of patients achieve objective response (tumor shrinkage) after receiving QL1706 plus GC, as measured by the objective response rate (ORR)? How long do the treatment benefits last, in terms of disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), and overall survival (OS)? What is the safety profile of QL1706 combined with GC, including the frequency and severity of adverse events, treatment-related adverse events, serious adverse events, and immune-related adverse events? Participants will receive QL1706 (5 mg/kg, intravenous infusion) once every 3 weeks in combination with gemcitabine (1000 mg/m² on days 1 and 8) and cisplatin (25 mg/m² on days 1 and 8) for up to 8 cycles (each cycle is 3 weeks), and after completing 8 cycles of combination therapy, they will continue QL1706 alone as maintenance therapy (5 mg/kg once every 3 weeks) until disease progression, unacceptable toxicity, withdrawal of consent, loss to follow-up, death, or completion of 2 years of treatment, whichever occurs first. Participants will undergo tumor imaging assessments (using CT or MRI) every 9 weeks (±7 days) during the treatment period, with responses evaluated . Participants will also have regular blood tests, physical examinations, electrocardiograms, and other safety assessments at each treatment cycle, and will provide tumor tissue and blood samples before treatment and at various time points during the study for biomarker analyses to explore correlations with treatment response. Finally, participants will be followed for adverse events for 30 days after the last dose, for serious adverse events for 90 days after the last dose, and for survival status every 90 days (±14 days) after the end of treatment until death, study completion, or loss to follow-up.
The study is expected to provide valuable evidence on whether the addition of QL1706 to standard GC chemotherapy offers a new treatment option for patients with PD-L1-positive advanced biliary tract cancer, and to identify potential biomarkers that may help predict which patients are most likely to benefit from this combination therapy.
- Conditions
- Biliary Tract Cancer (BTC)
- Being tested
- Iparomlimab and Tuvonralimab (QL1706), Gemcitabine and Cisplatin Chemotherapy
- Keywords
- Biliary Tract Cancer, Immunotherapy, Iparomlimab, Gemcitabine, Cisplatin, Tuvonralimab
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and Tuvonralimab (QL1706)Biological
QL1706 is a bifunctional combination antibody composed of a PD-1 monoclonal antibody (IgG4 isotype, no ADCC effect) and a CTLA-4 monoclonal antibody (IgG1 isotype, with ADCC effect, engineered with R255K mutation to shorten half-life and reduce toxicity). It is administered at 5 mg/kg via intravenous infusion once every 3 weeks.
Gemcitabine and Cisplatin ChemotherapyDrug
Gemcitabine is a nucleoside analog antimetabolite antineoplastic agent, and cisplatin is a platinum-based alkylating agent. The combination is administered as follows: gemcitabine 1000 mg/m² and cisplatin 25 mg/m² via intravenous infusion on days 1 and 8 of each 21-day cycle, for up to 8 cycles.
| Study group | Role | What they receive |
|---|---|---|
| QL1706 in Combination With GC First-Line Therapy | Experimental | Participants receive QL1706 (5 mg/kg, IV, once every 3 weeks) in combination with gemcitabine (1000 mg/m², IV, days 1 and 8, every 3 weeks) and cisplatin (25 mg/m², IV, days 1 and 8, every 3 weeks) for up to 8 cycles, followed by QL1706monotherapy maintenance (5 mg/kg, IV, once every 3 weeks) until disease progression, unacceptable toxicity, withdrawal of consent, loss to follow-up, death, or completion of 2 years of treatment, whichever occurs first. Receives: Biological: Iparomlimab and Tuvonralimab (QL1706); Drug: Gemcitabine and Cisplatin Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Proportion of participants with CR or PR per RECIST 1.1, assessed by investigator
Measured: Up to 24 months
Secondary outcomes (6)
Disease Control Rate (DCR)
DCR is defined as the proportion of participants achieving a best overall response of complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1 criteria, as assessed by the investigator.
Measured: Up to 24 months
Duration of Response (DOR)
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death due to any cause, whichever occurs first.
Measured: Up to 24 months
Time to Response (TTR)
TTR is defined as the time from enrollment to the first documented objective response (CR or PR).
Measured: Up to 24 months
Progression-Free Survival (PFS)
PFS is defined as the time from enrollment to the first documented radiographic disease progression or death due to any cause, whichever occurs first.
Measured: Up to 24 months
Overall Survival (OS)
OS is defined as the time from enrollment to death due to any cause.
Measured: Up to 36 months (or longer as follow-up continues)
Safety
Safety will be assessed by the incidence, severity, and relationship of adverse events (AEs)
Measured: Up to 30 days after last dose for AEs; up to 90 days after last dose for SAEs and irAEs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract Cancer (BTC)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhou, Shanghai Zhongshan Hospital
- Investigators
- Jian Zhou, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733115
- Sponsor's protocol ID
- QL1706-PDL1+BTC
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 29 Jul 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-Arm, Phase II Clinical Study of QL1706 in Combination With Gemcitabine and Cisplatin (GC) as First-Line Treatment for PD-L1-Positive Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT07733115
- Acronym / sponsor ID
- QL1706-PDL1+BTC
- Conditions
- Biliary Tract Cancer (BTC)
- Keywords
- Biliary Tract Cancer, Immunotherapy, Iparomlimab, Gemcitabine, Cisplatin, Tuvonralimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Jul 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.
The goal of this clinical trial is to evaluate whether QL1706(Iparomlimab/Tuvonralimab) in combination with gemcitabine and cisplatin (GC) is effective and safe as a first-line treatment for patients with advanced biliary tract cancer whose tumors are PD-L1 positive (CPS ≥ 1). This is a multicenter, single-arm, phase II clinical study. A total of 38 eligible patients will be enrolled .
The main questions it aims to answer are: what proportion of patients achieve objective response (tumor shrinkage) after receiving QL1706 plus GC, as measured by the objective response rate (ORR)? How long do the treatment benefits last, in terms of disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), and overall survival (OS)? What is the safety profile of QL1706 combined with GC, including the frequency and severity of adverse events, treatment-related adverse events, serious adverse events, and immune-related adverse events? Participants will receive QL1706 (5 mg/kg, intravenous infusion) once every 3 weeks in combination with gemcitabine (1000 mg/m² on days 1 and 8) and cisplatin (25 mg/m² on days 1 and 8) for up to 8 cycles (each cycle is 3 weeks), and after completing 8 cycles of combination therapy, they will continue QL1706 alone as maintenance therapy (5 mg/kg once every 3 weeks) until disease progression, unacceptable toxicity, withdrawal of consent, loss to follow-up, death, or completion of 2 years of treatment, whichever occurs first. Participants will undergo tumor imaging assessments (using CT or MRI) every 9 weeks (±7 days) during the treatment period, with responses evaluated . Participants will also have regular blood tests, physical examinations, electrocardiograms, and other safety assessments at each treatment cycle, and will provide tumor tissue and blood samples before treatment and at various time points during the study for biomarker analyses to explore correlations with treatment response. Finally, participants will be followed for adverse events for 30 days after the last dose, for serious adverse events for 90 days after the last dose, and for survival status every 90 days (±14 days) after the end of treatment until death, study completion, or loss to follow-up.
The study is expected to provide valuable evidence on whether the addition of QL1706 to standard GC chemotherapy offers a new treatment option for patients with PD-L1-positive advanced biliary tract cancer, and to identify potential biomarkers that may help predict which patients are most likely to benefit from this combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QL1706 in Combination With GC First-Line Therapy | Experimental | Biological: Iparomlimab and Tuvonralimab (QL1706), Drug: Gemcitabine and Cisplatin ChemotherapyParticipants receive QL1706 (5 mg/kg, IV, once every 3 weeks) in combination with gemcitabine (1000 mg/m², IV, days 1 and 8, every 3 weeks) and cisplatin (25 mg/m², IV, days 1 and 8, every 3 weeks) for up to 8 cycles, followed by QL1706monotherapy maintenance (5 mg/kg, IV, once every 3 weeks) until disease progression, unacceptable toxicity, withdrawal of consent, loss to follow-up, death, or completion of 2 years of treatment, whichever occurs first. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Have signed the written informed consent form and be able to comply with all scheduled visits and study procedures specified in the protocol.
- Aged between 18 and 75 years old (inclusive), with no restriction on gender.
- Histologically confirmed unresectable or metastatic advanced biliary tract adenocarcinoma, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer.
- PD-L1-positive tumor (Combined Positive Score [CPS] ≥ 1).
- Have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Key exclusion criteria (27 listed)
- Histologically or cytologically confirmed diagnosis of tumors containing components other than biliary adenocarcinoma (e.g., neuroendocrine carcinoma, squamous cell carcinoma, or mixed histologies).
- Prior treatment with anti-PD-1/PD-L1 agents, anti-CTLA-4 agents, or other antitumor immunotherapies.
- Presence of unresolved Grade >1 toxicities related to any previous antitumor therapy (persistent Grade 2 alopecia, fatigue, or endocrine disorders well-controlled with hormone replacement therapy are excluded).
- History of other malignancies within 5 years prior to enrollment, except for radically cured basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ with no evidence of recurrence, or other malignancies with complete remission and no active disease for at least 2 years prior to enrollment.
- Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first drug administration. Replacement therapies (e.g., levothyroxine, insulin, physiological corticosteroids for adrenal or pituitary insufficiency) are not regarded as systemic treatment. Known primary immunodeficiency. Patients with positive autoantibodies only should be assessed by the investigator for the presence of autoimmune disease.
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 |
|---|---|---|
| Iparomlimab and Tuvonralimab (QL1706)QL1706 is a bifunctional combination antibody composed of a PD-1 monoclonal antibody (IgG4 isotype, no ADCC effect) and a CTLA-4 monoclonal antibody (IgG1 isotype, with ADCC effect, engineered with R255K mutation to shorten half-life and reduce toxicity). It is administered at 5 mg/kg via intravenous infusion once every 3 weeks. | Biological | QL1706 in Combination With GC First-Line Therapy |
| Gemcitabine and Cisplatin ChemotherapyGemcitabine is a nucleoside analog antimetabolite antineoplastic agent, and cisplatin is a platinum-based alkylating agent. The combination is administered as follows: gemcitabine 1000 mg/m² and cisplatin 25 mg/m² via intravenous infusion on days 1 and 8 of each 21-day cycle, for up to 8 cycles. | Drug | QL1706 in Combination With GC First-Line Therapy |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to 24 months
Proportion of participants with CR or PR per RECIST 1.1, assessed by investigator
6 secondary outcomes
Disease Control Rate (DCR)
Time frame: Up to 24 months
Duration of Response (DOR)
Time frame: Up to 24 months
Time to Response (TTR)
Time frame: Up to 24 months
Progression-Free Survival (PFS)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 36 months (or longer as follow-up continues)
Safety
Time frame: Up to 30 days after last dose for AEs; up to 90 days after last dose for SAEs and irAEs
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 29 Jul 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.
Jian Zhou principal investigator
Fudan University
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 Iparomlimab and Tuvonralimab (QL1706) and Gemcitabine and Cisplatin Chemotherapy in people with Biliary Tract Cancer (BTC), run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 27 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 29 Jul 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 XiaoYong Huang (+86 15021519215, huang.xiaoyong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to 24 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 29 Jul 2026.