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Compares treatment options for Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
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
ClinicalTrials.gov ID: NCT06829797
What this study is testing
What is Neoadjuvant Therapy(QL1706+SOX Chemotherapy)?
Neoadjuvant Therapy(QL1706+SOX Chemotherapy) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for locally advanced gastric/gastroesophageal junction adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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);
You likely can't join if
- 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...
- History of gastrointestinal perforation, history of abdominal abscess or recent (within 3 months) occurrence of intestinal obstruction, or...
- Patients with abnormal coagulation (International Normalized Ratio (INR) \>2.0 or Prothrombin Time (PT) \>16s), a bleeding tendency or currently...
See the full eligibility 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.
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.