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)

April 24, 2026 updated by: Li Leping, Shandong Provincial Hospital

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250021
        • Recruiting
        • Shandong Provincial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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;
  • Be able to swallow pills normally;
  • ECOG-PS score 0-1;
  • Expected survival ≥ 12 months;
  • Normal major organ function.

Exclusion Criteria:

  • 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);
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: QL1706+SOX group
Drug: 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.
Procedure: Radical surgery (D2)
Surgical treatment is completed within 3-5 weeks after the end of neoadjuvant therapy.
Drug: Drug: Adjuvant therapy(QL1706+SOX chemotherapy)
Postoperative adjuvant therapy is 4 cycles of QL1706+SOX chemotherapy.
Active Comparator: SOX group
Procedure: Radical surgery (D2)
Surgical treatment is completed within 3-5 weeks after the end of neoadjuvant therapy.
Drug: Neoadjuvant Therapy(SOX Chemotherapy)
Preoperative SOX regimen (4 cycles) → radical surgery (D2) → postoperative SOX regimen (4 cycles).
Drug: Drug: Adjuvant therapy(SOX chemotherapy)
Postoperative adjuvant therapy is 4 cycles of SOX chemotherapy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 14-16 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
From study inception to patient death from any cause.
From the date of diagnosis to the date of death, assessed up to 60 months.
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.
The percentage of surviving tumor cells in the tumor bed after neoadjuvant therapy was ≤10%.
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.
The proportion of patients who completed R0 resection in the total enrolled patients.
From date of neoadjuvant therapy until the date of postoperative pathological assessment, assessed up to 14-16 weeks.
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.
The time from randomization until disease recurrence or death due to disease progression.
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.
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).
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.
Based on NCI-CTCAE (version 5.0) adverse events (AEs): including type, incidence, grading, severity, duration, and relevance to the study drug
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.
The proportion of dose interruptions, dose reductions, and discontinuations due to drug-related toxicity during the study period.
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.
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.
From the date of neoadjuvant therapy initiation until the end of postoperative follow-up, up to 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 29, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 29, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NO.2024-1046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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