Phase Ib/II Clinical Study of QL1706 Combined With SOX Perioperative Treatment for Resectable Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
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.
• 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;
• Normal functioning of major organs, including:
∙ Blood routine examination (no blood component, cell growth factor are allowed within 7 days before the first use of the study drug) :
∙ neutrophil count ≥ 1.5×109/L Platelet count ≥ 80×109/L Hemoglobin ≥ 80 g/L
‣ Blood biochemical examination:
∙ Total bilirubin ≤ 1.5 x ULN ALT ≤ 2.5 x ULN, AST ≤ 2.5 x ULN, Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 50 mL/min (Cocheroft-Gault formula)
‣ Coagulation function:
• International Standardized ratio (INR) ≤ 1.5 x ULN Activated partial thromboplastin time (APTT) ≤ 1.5 x ULN
⁃ Fertile female subjects are required to take a serum or urine pregnancy test that is negative within 72 hours prior to the start of the study drug administration, and to use effective contraception (such as Iuds, contraceptives, or condoms) during the trial period and for at least 120 days after the last dose; For male subjects whose partner is a fertile woman, they should be surgically sterilized or agree to use effective contraception during the trial and for 120 days after the last dose;
⁃ The subject have good compliance and cooperated well with the follow-up
⁃ Agreed to provide tumor tissue samples