Locally Advanced Gastric/Gastroesophageal Junction AdenocarcinomaPhase 2STAR-03NCT06829797
A Multicenter Randomized Controlled Phase II Trial of Iparomlimab and Tuvonralimab (QL1706) Combined With SOX Chemotherapy Versus Chemotherapy Alone in the Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
A Phase 2 study testing Neoadjuvant Therapy(QL1706+SOX Chemotherapy), Neoadjuvant Therapy(SOX Chemotherapy) and Radical surgery (D2) in people with Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
To explore the efficacy of Iparomlimab and Tuvonralimab (QL1706) in combination with SOX chemotherapy versus chemotherapy alone for the neoadjuvant treatment of locally-progressed gastric/gastroesophageal union adenocarcinomas by evaluating the complete pathologic remission rate (pCR). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Neoadjuvant Therapy(QL1706+SOX Chemotherapy), Neoadjuvant Therapy(SOX Chemotherapy) and Radical surgery (D2)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2025to 29 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation in the study and signing of informed consent;
- Age ≥18 years and ≤75 years;
- Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma;
- Clinical staging of T3N+ or T4a any N, M0 (according to AJCC 8th edition staging), with potential radical resection confirmed by CT or MRI;
- Have not received any anti-tumor therapy (e.g., surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy);
- Planned to undergo surgery after completion of neoadjuvant therapy;
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- Be able to swallow pills normally;
- ECOG-PS score 0-1;
- Expected survival ≥ 12 months;
- Normal major organ function.
Who cannot join
- Known HER2 positivity;
- Known peritoneal metastases or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition);
- Presence of unresectable factors including unresectable tumors, contraindications to surgery and refusal of surgery;
- The presence of a pre-existing or concurrent malignancy, with the exception of cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and carcinoma in situ of the breast
- History of gastrointestinal perforation, history of abdominal abscess or recent (within 3 months) occurrence of intestinal obstruction, or concomitant intestinal obstruction as indicated by imaging or clinical signs;
- Patients with abnormal coagulation (International Normalized Ratio (INR) >2.0 or Prothrombin Time (PT) >16s), a bleeding tendency or currently receiving thrombolytic or anticoagulant therapy (prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed);
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- Clinically significant bleeding symptoms or significant bleeding tendency such as gastrointestinal bleeding, gastric ulcer bleeding, and vasculitis within 3 months prior to randomization into groups. Patients with positive fecal occult blood at baseline may be retested, and if the retest remains positive, gastroscopy will be required (except for patients who have had a gastroscopy within 3 months prior to enrollment to rule out this condition);
- Arterial/venous thrombotic events such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, and cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to randomization to group;
- A known hereditary or acquired predisposition to bleeding and thrombosis (e.g., hemophilia, coagulation disorders, and thrombocytopenia);
- The presence of active ulcers, unhealed wounds or fractures
- Urinalysis showing urinary protein ≥++, confirmed by 24-hour urine protein quantification >1.0 g;
- Active infections requiring antimicrobial therapy (e.g., antibacterial, antiviral, and antifungal medications);
- Active hepatitis (Hepatitis B reference: HBsAg positive and HBV DNA ≥ 500 IU/mL; Hepatitis C reference: HCV antibody positive and HCV viral copy number > upper limit of normal (ULN));
- Congenital or acquired immunodeficiency (e.g., HIV-infected patients);
- Planned or previous organ or allogeneic bone marrow transplant;
- Current interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia or interstitial lung disease requiring hormonal therapy, or other conditions that may interfere with the assessment and management of immune-related pulmonary toxicity, such as pulmonary fibrosis, opportunistic pneumonia (e.g., occlusive bronchiectasis), pneumoconiosis, drug-associated pneumonia, and idiopathic pneumonitis, or active pneumonitis or severe pulmonary impairment as demonstrated by CT at screening; Active tuberculosis;
- Any active autoimmune disease or history of autoimmune disease with potential for relapse;
- Treatment with immunosuppressive drugs or systemic corticosteroids (>10 mg/day of prednisone or equivalent) within 7 days prior to randomization to group;
- Use of a strong CYP3A4 inducer within 2 weeks prior to randomization subgroup or use of a strong CYP3A4 inhibitor within 1 week prior to randomization subgroup
- Oral or intravenous administration of therapeutic antibiotics within 4 weeks prior to randomization to subgroups, except for prophylactic antibiotics administered intravenously for no more than 48 hours
- Known allergy to any study drug or excipient;
- Participation in a clinical study of another drug within 4 weeks prior to randomization to group;
- Being a lactating female.
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
Shandong Provincial Hospital
Jinan, Shandong, 250021
Liang Shang, doctor, 15866602157, shangliang@sdfmu.edu.cn
About this study
Official title: A Multicenter Randomized Controlled Phase II Trial of Iparomlimab and Tuvonralimab (QL1706) Combined With SOX Chemotherapy Versus Chemotherapy Alone in the Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma(STAR-03)
To explore the efficacy of Iparomlimab and Tuvonralimab (QL1706) in combination with SOX chemotherapy versus chemotherapy alone for the neoadjuvant treatment of locally-progressed gastric/gastroesophageal union adenocarcinomas by evaluating the complete pathologic remission rate (pCR).
- Being tested
- Neoadjuvant Therapy(QL1706+SOX Chemotherapy), Neoadjuvant Therapy(SOX Chemotherapy), Radical surgery (D2), Drug: Adjuvant therapy(QL1706+SOX chemotherapy), Drug: Adjuvant therapy(SOX chemotherapy)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant Therapy(QL1706+SOX Chemotherapy)Drug
Preoperative QL1706 combined with SOX regimen (4 cycles) → Radical surgery (D2) → Postoperative QL1706 combined with SOX regimen (4 cycles). QL1706 (50mg/2mL) , at a dose of 5mg/kg, the desired volume of drug is withdrawn and slowly infused into an IV bag of 0.9% NaCl, prepared as a diluent with a final concentration of 1-10mg/mL, mixed, and infused intravenously, Q3W, administered on the first day of each cycle.
Neoadjuvant Therapy(SOX Chemotherapy)Drug
Preoperative SOX regimen (4 cycles) → radical surgery (D2) → postoperative SOX regimen (4 cycles).
Radical surgery (D2)Procedure or surgery
Surgical treatment is completed within 3-5 weeks after the end of neoadjuvant therapy.
Drug: Adjuvant therapy(QL1706+SOX chemotherapy)Drug
Postoperative adjuvant therapy is 4 cycles of QL1706+SOX chemotherapy.
Drug: Adjuvant therapy(SOX chemotherapy)Drug
Postoperative adjuvant therapy is 4 cycles of SOX chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| QL1706+SOX group | Experimental | Not described Receives: Drug: Neoadjuvant Therapy(QL1706+SOX Chemotherapy); Procedure: Radical surgery (D2); Drug: Drug: Adjuvant therapy(QL1706+SOX chemotherapy) |
| SOX group | Active comparator | Not described Receives: Drug: Neoadjuvant Therapy(SOX Chemotherapy); Procedure: Radical surgery (D2); Drug: Drug: Adjuvant therapy(SOX chemotherapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate (pCR)
Pathological complete response was defined as pT0N0M0
Measured: From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 14-16 weeks.
Secondary outcomes (9)
Major pathological response rate (MPR)
The percentage of surviving tumor cells in the tumor bed after neoadjuvant therapy was ≤10%.
Measured: From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 14-16 weeks.
R0 resection rate
The proportion of patients who completed R0 resection in the total enrolled patients.
Measured: From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 14-16 weeks.
Event-free survival (EFS)
From the beginning of the study to the time of the first occurrence of any of the following events, disease progression beyond surgical treatment, local or distant recurrence, death from any cause, etc.
Measured: From date of neoadjuvant therapy until the date of the first occurrence of the above events, assessed up to 60 months.
Overall survival (OS)
From study inception to patient death from any cause.
Measured: From the date of diagnosis to the date of death, assessed up to 60 months.
Disease-free survival (DFS)
The time from randomization until disease recurrence or death due to disease progression.
Measured: From date of neoadjuvant therapy until the date of the disease recurrence or death due to disease progression, assessed up to 60 months.
Surgical safety
The occurrence of postoperative complications including surgical site infection, anastomotic leakage, gastrointestinal bleeding, incisional dehiscence, adhesive bowel obstruction, biliary and celiac fistulae, and unexplained fever (≥37.5°C).
Measured: From date of neoadjuvant therapy until the date of 30 days post-surgery, assessed up to 17-19 weeks.
Adverse Events
Based on NCI-CTCAE (version 5.0) adverse events (AEs): including type, incidence, grading, severity, duration, and relevance to the study drug
Measured: From the date of neoadjuvant therapy to the completion of postoperative adjuvant therapy, up to 24 months.
Drug tolerance
The proportion of dose interruptions, dose reductions, and discontinuations due to drug-related toxicity during the study period.
Measured: From the date of neoadjuvant therapy to the completion of postoperative adjuvant therapy, up to 24-28 weeks.
Prognostic Biomarkers
Biomarkers of interest include PD-L1 expression (assessed by IHC), microsatellite instability (MSI) status (determined by PCR-based testing), tumor mutation burden (TMB) (evaluated using next-generation sequencing), and circulating tumor DNA (ctDNA) levels (quantified via liquid biopsy). The correlation between these biomarkers and treatment efficacy, including progression-free survival (PFS) and overall survival (OS), will be analyzed.
Measured: From the date of neoadjuvant therapy initiation until the end of postoperative follow-up, up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start11 Mar 2025
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Gastric/Gastroesophageal Junction AdenocarcinomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Li Leping, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829797
- Sponsor's protocol ID
- NO.2024-1046
- Acronym
- STAR-03
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2025
- Last updated
- 29 Apr 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Phase II Trial of Iparomlimab and Tuvonralimab (QL1706) Combined With SOX Chemotherapy Versus Chemotherapy Alone in the Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma(STAR-03)
- ClinicalTrials.gov ID
- NCT06829797
- Acronym / sponsor ID
- STAR-03 / NO.2024-1046
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 17 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.
To explore the efficacy of Iparomlimab and Tuvonralimab (QL1706) in combination with SOX chemotherapy versus chemotherapy alone for the neoadjuvant treatment of locally-progressed gastric/gastroesophageal union adenocarcinomas by evaluating the complete pathologic remission rate (pCR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL1706+SOX group | Experimental | Drug: Neoadjuvant Therapy(QL1706+SOX Chemotherapy), Procedure: Radical surgery (D2), Drug: Drug: Adjuvant therapy(QL1706+SOX chemotherapy) |
| SOX group | Active comparator | Drug: Neoadjuvant Therapy(SOX Chemotherapy), Procedure: Radical surgery (D2), Drug: Drug: Adjuvant therapy(SOX chemotherapy) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntary participation in the study and signing of informed consent;
- Age ≥18 years and ≤75 years;
- Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma;
- Clinical staging of T3N+ or T4a any N, M0 (according to AJCC 8th edition staging), with potential radical resection confirmed by CT or MRI;
- Have not received any anti-tumor therapy (e.g., surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy);
Key exclusion criteria (23 listed)
- Known HER2 positivity;
- Known peritoneal metastases or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition);
- Presence of unresectable factors including unresectable tumors, contraindications to surgery and refusal of surgery;
- The presence of a pre-existing or concurrent malignancy, with the exception of cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and carcinoma in situ of the breast
- History of gastrointestinal perforation, history of abdominal abscess or recent (within 3 months) occurrence of intestinal obstruction, or concomitant intestinal obstruction as indicated by imaging or clinical signs;
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 |
|---|---|---|
| Neoadjuvant Therapy(QL1706+SOX Chemotherapy)Preoperative QL1706 combined with SOX regimen (4 cycles) → Radical surgery (D2) → Postoperative QL1706 combined with SOX regimen (4 cycles). QL1706 (50mg/2mL) , at a dose of 5mg/kg, the desired volume of drug is withdrawn and slowly infused into an IV bag of 0.9% NaCl, prepared as a diluent with a final concentration of 1-10mg/mL, mixed, and infused intravenously, Q3W, administered on the first day of each cycle. | Drug | QL1706+SOX group |
| Neoadjuvant Therapy(SOX Chemotherapy)Preoperative SOX regimen (4 cycles) → radical surgery (D2) → postoperative SOX regimen (4 cycles). | Drug | SOX group |
| Radical surgery (D2)Surgical treatment is completed within 3-5 weeks after the end of neoadjuvant therapy. | Procedure or surgery | QL1706+SOX group, SOX group |
| Drug: Adjuvant therapy(QL1706+SOX chemotherapy)Postoperative adjuvant therapy is 4 cycles of QL1706+SOX chemotherapy. | Drug | QL1706+SOX group |
| Drug: Adjuvant therapy(SOX chemotherapy)Postoperative adjuvant therapy is 4 cycles of SOX chemotherapy. | Drug | SOX group |
Primary outcome
Pathological complete response rate (pCR)
Time frame: From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 14-16 weeks.
Pathological complete response was defined as pT0N0M0
9 secondary outcomes
Major pathological response rate (MPR)
Time frame: From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 14-16 weeks.
R0 resection rate
Time frame: From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 14-16 weeks.
Event-free survival (EFS)
Time frame: From date of neoadjuvant therapy until the date of the first occurrence of the above events, assessed up to 60 months.
Overall survival (OS)
Time frame: From the date of diagnosis to the date of death, assessed up to 60 months.
Disease-free survival (DFS)
Time frame: From date of neoadjuvant therapy until the date of the disease recurrence or death due to disease progression, assessed up to 60 months.
Surgical safety
Time frame: From date of neoadjuvant therapy until the date of 30 days post-surgery, assessed up to 17-19 weeks.
Adverse Events
Time frame: From the date of neoadjuvant therapy to the completion of postoperative adjuvant therapy, up to 24 months.
Drug tolerance
Time frame: From the date of neoadjuvant therapy to the completion of postoperative adjuvant therapy, up to 24-28 weeks.
Prognostic Biomarkers
Time frame: From the date of neoadjuvant therapy initiation until the end of postoperative follow-up, up to 24 months.
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 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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 Neoadjuvant Therapy(QL1706+SOX Chemotherapy), Neoadjuvant Therapy(SOX Chemotherapy) and Radical surgery (D2) in people with Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma, run by Shandong Provincial 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 10 inclusion and 23 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 Apr 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 Liang Shang (+8615866602157, docshang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (pCR) (time frame: From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 14-16 weeks.). 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 Apr 2026.