QL1706 Combined With SOX Used in Theperioperative Treatment (NCT06766305) | Clinical Trial Compass
RecruitingPhase 1/2
QL1706 Combined With SOX Used in Theperioperative Treatment
China54 participantsStarted 2025-03-21
Plain-language summary
This is a single-center, single-arm clinical study to evaluate the efficacy and safety of QL1706 combined with SOX for the treatment of resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.
The study consists of the following two phases:
Phase 1: The safety introduction phase of QL1706 combined with SOX, using a 3+3 design, enrolled about 6 to 12 patients with locally advanced gastric/gastroesophageal junction adenocarcinoma (primary clinical stage ≥T3 or N+, M0) and underwent 3-week DLT evaluation.
Phase 2: This phase plans to enroll 42 to 45 patients, using investigator-evaluated pCR as the primary endpoint. QL1706 is administered by intravenous infusion of RP2D as defined in Part 1 starting from cycle 1.
Preoperative QL1706 RP2D combined with SOX (3 cycles) → radical surgery (D2) → postoperative QL1706 RP2D combined with SOX (5 cycles) → postoperative maintenance of QL1706 RP2D (up to 1 year before and after surgery); neoadjuvant therapy Surgery should be performed within 3 to 6 weeks after the last dosing, with a minimum interval of 4 weeks after surgery and a maximum interval of 6 weeks recommended for postoperative adjuvant therapy.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Sign a written informed consent to join the study voluntarily;
✓. Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction;
✓. Adenocarcinoma of the stomach or gastroesophageal junction was evaluated by CT/MRI (primary clinical stage ≥T3 or N+, M0, according to AJCC 8th edition staging), including Siewert type II and III tumors
✓. Age 18-75 years old, male or female;
✓. ECOG PS 0-1 ;
✓. Have not received any anti-tumor treatment for gastric or gastroesophageal junction adenocarcinoma, including radiotherapy, chemotherapy, surgery, etc.;
✓. Surgical treatment is planned after the completion of neoadjuvant therapy, and R0 resection is expected;
✓. Expected survival ≥6 months;
Exclusion criteria
✕. There are unresectable factors, including unresectable tumor causes or unresectable or refused surgery contraindications;
✕. Have received or are receiving any of the following treatment:
✕. any radiation therapy, chemotherapy, or immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.) and other anti-tumor drugs;
✕. being treated with immunosuppressive drugs or systemic hormones for immunosuppressive purposes within 2 weeks prior to the initial use of the investigational drug (dose \>10mg/ day prednisone or equivalent); In the absence of active autoimmune disease, inhaled or topical steroid use and adrenocortical hormone replacement with doses \>10mg/ day of prednisone or equivalent are permitted;
✕. Received live attenuated vaccine within 4 weeks prior to the first use of the investigational drug; If enrolled, subjects must not receive live vaccine during the study period or within 120 days after the last administration of QL1706;
✕. Serious infections (CTCAE \> Grade 2) occurred within 4 weeks prior to the first use of the study drug, such as severe pneumonia, bacteremia, and infection complications requiring hospitalization; Baseline chest imaging indicated active pulmonary inflammation, signs and symptoms of infection within 14 days prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except in cases of prophylactic antibiotic use;
✕. Patients with active autoimmune disease requiring systemic treatment within 2 years prior to initial use of the investigational drug or a history of autoimmune disease with recurrence possible \[including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (which can be controlled by hormone replacement therapy alone) Patients can be enrolled)\];
✕. A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation;