Gastric CancerPhase 2NCT07692334
Becotatugvedotin Plus Pucotenlimab in EGFR-Positive Advanced Gastric/GEJ Adenocarcinoma
A Phase 2 study testing Becotatug Vedotin (MRG003) and Pucotenlimab in people with Gastric Cancer and Gastroesophageal Junction (GEJ) Adenocarcinoma, run by West China Second University Hospital.
Trial summary
Advanced gastric cancer (AGC) and gastroesophageal junction (GEJ) adenocarcinoma remain associated with poor prognosis after failure of first-line systemic therapy. Although immune checkpoint inhibitor-based chemoimmunotherapy has become the standard first-line treatment for HER2-negative advanced disease, most… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction (GEJ) Adenocarcinoma, Becotatug Vedotin
- What is being tested?
- Becotatug Vedotin (MRG003) and Pucotenlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2026to 31 Dec 2027
- 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
- Voluntarily provide written informed consent and be willing and able to comply with all study procedures and follow-up requirements.
- Age 18 to 75 years, regardless of sex.
- Histologically or cytologically confirmed unresectable locally advanced, recurrent, or metastatic gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma.
- EGFR-positive tumor confirmed by immunohistochemistry (IHC) performed on archival or newly obtained tumor tissue. EGFR positivity is defined as IHC 1+, 2+, 3+, or 4+, corresponding to membrane staining in ≥1% of tumor cells.
- Disease progression, recurrence, or intolerance following one prior line of systemic therapy for advanced or metastatic disease, including a fluoropyrimidine- and platinum-based regimen with or without a PD-1 inhibitor, and considered eligible for second-line treatment. Patients who relapse within 6 months after completion of neoadjuvant or adjuvant chemotherapy are considered to have failed first-line therapy.
- At least one measurable lesion according to RECIST version 1.1.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Estimated life expectancy of at least 12 weeks.
- Adequate organ function within 14 days prior to enrollment:
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; Platelet count ≥100 × 10⁹/L; Hemoglobin ≥90 g/L; Total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤2.5 × ULN (≤5 × ULN in patients with liver metastases); Serum creatinine ≤1.5 × ULN or creatinine clearance (CrCl) ≥50 mL/min; INR ≤1.5 × ULN, or therapeutic anticoagulation with stable coagulation parameters considered acceptable by the investigator.
- Women of childbearing potential must have a negative pregnancy test before enrollment. Male and female participants of reproductive potential must agree to use effective contraception during study treatment and for at least 6 months after the last dose of study drug.
Who cannot join
- Prior treatment with any EGFR-targeting antibody-drug conjugate (ADC), including becotatug vedotin (MRG003) or similar EGFR-targeting ADCs. Previous treatment with anti-EGFR monoclonal antibodies (e.g., cetuximab) is permitted.
- Receipt of chemotherapy, targeted therapy, immunotherapy, or other anti-cancer therapy within 4 weeks before study treatment initiation, or unresolved treatment-related toxicities > Grade 1 (except alopecia). Radiotherapy within 4 weeks (or palliative radiotherapy within 2 weeks) before enrollment.
- HER2-positive disease (IHC 3+ or IHC 2+ with ISH/FISH amplification).
- Untreated or uncontrolled central nervous system (CNS) metastases or leptomeningeal disease. Patients with previously treated brain metastases may be enrolled if clinically stable for at least 4 weeks and receiving no more than prednisone 10 mg/day (or equivalent).
- Current or previous interstitial lung disease (ILD), immune-related pneumonitis, or active pneumonitis requiring systemic corticosteroid treatment.
- Active autoimmune disease requiring systemic immunosuppressive therapy, or history of organ transplantation requiring immunosuppressive treatment.
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- Uncontrolled active infection, including severe bacterial infection requiring intravenous antibiotics, active tuberculosis, hepatitis B virus (HBV) DNA >2,000 IU/mL or without appropriate antiviral therapy, untreated hepatitis C virus (HCV) infection with detectable HCV RNA, or uncontrolled human immunodeficiency virus (HIV) infection.
- Significant cardiovascular or other serious uncontrolled systemic diseases, including myocardial infarction, unstable angina, New York Heart Association (NYHA) class III-IV heart failure, severe arrhythmia, QTc >470 ms within 6 months before enrollment, or any other condition judged by the investigator to interfere with study participation.
- Baseline Grade ≥2 peripheral neuropathy or clinically significant sensory neuropathy.
- Active gastrointestinal bleeding, gastrointestinal perforation, bowel obstruction, or gastrointestinal conditions requiring urgent surgical or interventional treatment.
- History of another active malignancy within the previous 5 years, except adequately treated basal cell carcinoma of the skin, cervical carcinoma in situ, or other malignancies with negligible risk of recurrence.
- Pregnant or breastfeeding women, or individuals planning pregnancy during the study period.
- Known severe hypersensitivity to becotatug vedotin, pucotenlimab, or any of their excipients.
- Any medical, psychiatric, social, or compliance-related condition that, in the opinion of the investigator, would compromise participant safety, interfere with study participation, or affect interpretation of study results.
- Participation in another interventional clinical trial within 4 weeks before enrollment or concurrent participation in another clinical trial involving investigational agents.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm, Open-Label, Phase II Study of Becotatugvedotin Combined With Pucotenlimab in Patients With EGFR-Positive Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed Standard First-Line Therapy
Advanced gastric cancer (AGC) and gastroesophageal junction (GEJ) adenocarcinoma remain associated with poor prognosis after failure of first-line systemic therapy. Although immune checkpoint inhibitor-based chemoimmunotherapy has become the standard first-line treatment for HER2-negative advanced disease, most patients eventually experience disease progression. Current second-line treatment options provide limited clinical benefit, highlighting the need for novel therapeutic strategies.
Epidermal growth factor receptor (EGFR) is overexpressed in approximately 20-30% of gastric cancers and is associated with aggressive tumor biology and poor prognosis. Previous studies evaluating anti-EGFR monoclonal antibodies or tyrosine kinase inhibitors in unselected gastric cancer populations failed to demonstrate survival benefit, largely because of the lack of biomarker-based patient selection and the limited efficacy of conventional EGFR-targeted agents. Becotatug vedotin (MRG003), an EGFR-directed antibody-drug conjugate (ADC) carrying monomethyl auristatin E (MMAE), exerts potent cytotoxic activity through EGFR-mediated internalization and intracellular payload release. In addition, MMAE-containing ADCs may induce immunogenic cell death and remodel the tumor immune microenvironment, providing a strong biological rationale for combination with programmed cell death protein-1 (PD-1) blockade. Pucotenlimab is a humanized anti-PD-1 monoclonal antibody with demonstrated antitumor activity and favorable safety in multiple solid tumors.
Read more
This is a prospective, single-center, open-label, single-arm phase II investigator-initiated trial designed to evaluate the efficacy and safety of becotatug vedotin in combination with pucotenlimab as second-line treatment in patients with EGFR-positive unresectable locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma who have progressed after standard first-line therapy. Approximately 28 patients will be enrolled. Participants will receive becotatug vedotin (2.0 mg/kg, intravenous infusion, every 3 weeks) plus pucotenlimab (200 mg, intravenous infusion, every 3 weeks) until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.
The primary endpoint is objective response rate (ORR) assessed according to RECIST version 1.1. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DoR), time to response (TTR), and safety. Exploratory analyses will evaluate the association between treatment outcomes and biomarkers including EGFR expression, PD-L1 expression, tumor mutational burden, microsatellite instability/mismatch repair status, and immune-related biomarkers, aiming to identify patients most likely to benefit from this combination therapy.
- Conditions
- Gastric Cancer, Gastroesophageal Junction (GEJ) Adenocarcinoma, Becotatug Vedotin, Pucotenlimab
- Being tested
- Becotatug Vedotin (MRG003), Pucotenlimab
- Medical subject headings
- Stomach Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Becotatug Vedotin (MRG003)Drug
Becotatug vedotin (MRG003) is an epidermal growth factor receptor (EGFR)-targeting antibody-drug conjugate (ADC) conjugated with monomethyl auristatin E (MMAE). It is administered intravenously at a dose of 2.0 mg/kg every 3 weeks (Q3W).
PucotenlimabDrug
Pucotenlimab is a humanized anti-programmed cell death protein-1 (PD-1) monoclonal antibody administered intravenously at a fixed dose of 200 mg every 3 weeks (Q3W).
| Study group | Role | What they receive |
|---|---|---|
| Becotatug Vedotin Plus Pucotenlimab | Experimental | Participants with EGFR-positive unresectable locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma who have progressed after standard first-line therapy will receive becotatug vedotin (2.0 mg/kg, intravenous infusion, every 3 weeks) in combination with pucotenlimab (200 mg, intravenous infusion, every 3 weeks) until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision. Receives: Drug: Becotatug Vedotin (MRG003); Drug: Pucotenlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) as their best overall response, as assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by an Independent Radiologic Review Committee (IRC).
Measured: From the first dose of study treatment until disease progression, initiation of new anti-cancer therapy, withdrawal from study, death, or up to approximately 24 months.
Secondary outcomes (6)
Disease control rate (DCR)
Disease control rate (DCR) is defined as the proportion of participants who achieve a confirmed complete response (CR), partial response (PR), or stable disease (SD) as their best overall response according to RECIST version 1.1, as assessed by an Independent Radiologic Review Committee (IRC).
Measured: From the first dose of study treatment until disease progression, initiation of new anti-cancer therapy, withdrawal from study, death, or up to approximately 24 months.
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from the first dose of study treatment to the first documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Measured: From the first dose of study treatment until documented disease progression, death from any cause, or up to approximately 24 months.
Overall Survival (OS)
Overall survival (OS) is defined as the time from the first dose of study treatment until death from any cause.
Measured: From the first dose of study treatment until death from any cause or up to approximately 24 months.
Duration of Response (DoR)
Duration of response (DoR) is defined for participants who achieve a confirmed complete response (CR) or partial response (PR), as the time from the first documented objective response until documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Measured: From the first documented objective response until disease progression, death, or up to approximately 24 months.
Time to Response (TTR)
Time to response (TTR) is defined for participants who achieve a confirmed complete response (CR) or partial response (PR), as the time from the first dose of study treatment to the first documented objective response according to RECIST version 1.1.
Measured: From the first dose of study treatment until the first documented objective response or up to approximately 24 months.
Treatment-Emergent Adverse Events (TEAEs)
Safety will be evaluated by the incidence, severity, and relationship of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), laboratory abnormalities, vital signs, physical examinations, and treatment discontinuations due to adverse events. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.
Measured: From the first dose of study treatment until 30 days after the last dose of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-center, open-label, single-arm, phase II investigator-initiated trial. All enrolled participants with EGFR-positive unresectable locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma who have experienced disease progression following standard first-line therapy will receive becotatug vedotin in combination with pucotenlimab. The study is designed to evaluate the efficacy and safety of this combination regimen, with objective response rate (ORR) as the primary endpoint.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Second University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting Liu, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692334
- Sponsor's protocol ID
- GC-EGFR-Ⅱ
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 9 Jul 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 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Phase II Study of Becotatugvedotin Combined With Pucotenlimab in Patients With EGFR-Positive Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed Standard First-Line Therapy
- ClinicalTrials.gov ID
- NCT07692334
- Acronym / sponsor ID
- GC-EGFR-Ⅱ
- Conditions
- Gastric Cancer, Gastroesophageal Junction (GEJ) Adenocarcinoma, Becotatug Vedotin, Pucotenlimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- West China Second University HospitalUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 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.
Advanced gastric cancer (AGC) and gastroesophageal junction (GEJ) adenocarcinoma remain associated with poor prognosis after failure of first-line systemic therapy. Although immune checkpoint inhibitor-based chemoimmunotherapy has become the standard first-line treatment for HER2-negative advanced disease, most patients eventually experience disease progression. Current second-line treatment options provide limited clinical benefit, highlighting the need for novel therapeutic strategies.
Epidermal growth factor receptor (EGFR) is overexpressed in approximately 20-30% of gastric cancers and is associated with aggressive tumor biology and poor prognosis. Previous studies evaluating anti-EGFR monoclonal antibodies or tyrosine kinase inhibitors in unselected gastric cancer populations failed to demonstrate survival benefit, largely because of the lack of biomarker-based patient selection and the limited efficacy of conventional EGFR-targeted agents. Becotatug vedotin (MRG003), an EGFR-directed antibody-drug conjugate (ADC) carrying monomethyl auristatin E (MMAE), exerts potent cytotoxic activity through EGFR-mediated internalization and intracellular payload release. In addition, MMAE-containing ADCs may induce immunogenic cell death and remodel the tumor immune microenvironment, providing a strong biological rationale for combination with programmed cell death protein-1 (PD-1) blockade. Pucotenlimab is a humanized anti-PD-1 monoclonal antibody with demonstrated antitumor activity and favorable safety in multiple solid tumors.
This is a prospective, single-center, open-label, single-arm phase II investigator-initiated trial designed to evaluate the efficacy and safety of becotatug vedotin in combination with pucotenlimab as second-line treatment in patients with EGFR-positive unresectable locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma who have progressed after standard first-line therapy. Approximately 28 patients will be enrolled. Participants will receive becotatug vedotin (2.0 mg/kg, intravenous infusion, every 3 weeks) plus pucotenlimab (200 mg, intravenous infusion, every 3 weeks) until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.
The primary endpoint is objective response rate (ORR) assessed according to RECIST version 1.1. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DoR), time to response (TTR), and safety. Exploratory analyses will evaluate the association between treatment outcomes and biomarkers including EGFR expression, PD-L1 expression, tumor mutational burden, microsatellite instability/mismatch repair status, and immune-related biomarkers, aiming to identify patients 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
- Model description
- This is a prospective, single-center, open-label, single-arm, phase II investigator-initiated trial. All enrolled participants with EGFR-positive unresectable locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma who have experienced disease progression following standard first-line therapy will receive becotatug vedotin in combination with pucotenlimab. The study is designed to evaluate the efficacy and safety of this combination regimen, with objective response rate (ORR) as the primary endpoint.
| Arm | Type | Receives |
|---|---|---|
| Becotatug Vedotin Plus Pucotenlimab | Experimental | Drug: Becotatug Vedotin (MRG003), Drug: PucotenlimabParticipants with EGFR-positive unresectable locally advanced, recurrent, or metastatic gastric or gastroesophageal junction adenocarcinoma who have progressed after standard first-line therapy will receive becotatug vedotin (2.0 mg/kg, intravenous infusion, every 3 weeks) in combination with pucotenlimab (200 mg, intravenous infusion, every 3 weeks) until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntarily provide written informed consent and be willing and able to comply with all study procedures and follow-up requirements.
- Age 18 to 75 years, regardless of sex.
- Histologically or cytologically confirmed unresectable locally advanced, recurrent, or metastatic gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma.
- EGFR-positive tumor confirmed by immunohistochemistry (IHC) performed on archival or newly obtained tumor tissue. EGFR positivity is defined as IHC 1+, 2+, 3+, or 4+, corresponding to membrane staining in ≥1% of tumor cells.
- Disease progression, recurrence, or intolerance following one prior line of systemic therapy for advanced or metastatic disease, including a fluoropyrimidine- and platinum-based regimen with or without a PD-1 inhibitor, and considered eligible for second-line treatment. Patients who relapse within 6 months after completion of neoadjuvant or adjuvant chemotherapy are considered to have failed first-line therapy.
Key exclusion criteria (15 listed)
- Prior treatment with any EGFR-targeting antibody-drug conjugate (ADC), including becotatug vedotin (MRG003) or similar EGFR-targeting ADCs. Previous treatment with anti-EGFR monoclonal antibodies (e.g., cetuximab) is permitted.
- Receipt of chemotherapy, targeted therapy, immunotherapy, or other anti-cancer therapy within 4 weeks before study treatment initiation, or unresolved treatment-related toxicities > Grade 1 (except alopecia). Radiotherapy within 4 weeks (or palliative radiotherapy within 2 weeks) before enrollment.
- HER2-positive disease (IHC 3+ or IHC 2+ with ISH/FISH amplification).
- Untreated or uncontrolled central nervous system (CNS) metastases or leptomeningeal disease. Patients with previously treated brain metastases may be enrolled if clinically stable for at least 4 weeks and receiving no more than prednisone 10 mg/day (or equivalent).
- Current or previous interstitial lung disease (ILD), immune-related pneumonitis, or active pneumonitis requiring systemic corticosteroid treatment.
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 |
|---|---|---|
| Becotatug Vedotin (MRG003)Becotatug vedotin (MRG003) is an epidermal growth factor receptor (EGFR)-targeting antibody-drug conjugate (ADC) conjugated with monomethyl auristatin E (MMAE). It is administered intravenously at a dose of 2.0 mg/kg every 3 weeks (Q3W). | Drug | Becotatug Vedotin Plus Pucotenlimab |
| PucotenlimabPucotenlimab is a humanized anti-programmed cell death protein-1 (PD-1) monoclonal antibody administered intravenously at a fixed dose of 200 mg every 3 weeks (Q3W). | Drug | Becotatug Vedotin Plus Pucotenlimab |
Primary outcome
Objective Response Rate (ORR)
Time frame: From the first dose of study treatment until disease progression, initiation of new anti-cancer therapy, withdrawal from study, death, or up to approximately 24 months.
Objective response rate (ORR) is defined as the proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) as their best overall response, as assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by an Independent Radiologic Review Committee (IRC).
6 secondary outcomes
Disease control rate (DCR)
Time frame: From the first dose of study treatment until disease progression, initiation of new anti-cancer therapy, withdrawal from study, death, or up to approximately 24 months.
Progression-Free Survival (PFS)
Time frame: From the first dose of study treatment until documented disease progression, death from any cause, or up to approximately 24 months.
Overall Survival (OS)
Time frame: From the first dose of study treatment until death from any cause or up to approximately 24 months.
Duration of Response (DoR)
Time frame: From the first documented objective response until disease progression, death, or up to approximately 24 months.
Time to Response (TTR)
Time frame: From the first dose of study treatment until the first documented objective response or up to approximately 24 months.
Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the first dose of study treatment until 30 days after the last dose of study treatment.
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 9 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Becotatug Vedotin (MRG003) and Pucotenlimab in people with Gastric Cancer and Gastroesophageal Junction (GEJ) Adenocarcinoma, run by West China Second University Hospital.
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 11 inclusion and 15 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 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qing Li, PhD (+8618702848178, liqing@scu.edu.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: From the first dose of study treatment until disease progression, initiation of new anti-cancer therapy, withdrawal from study, death, or up to approximately 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 9 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.