QL1706 Combined With SOX Used in Theperioperative Treatment
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXiangdong Cheng
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
There are unresectable factors, including unresectable tumor causes or unresectable or refused surgery contraindications;
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;
Trial design
Treatments tested in this trial
- QL1706 combined with SOX
Treatment groups
54 Participants
are divided into 1 treatment groupSponsors and collaborators
Xiangdong Cheng
Lead sponsor
Zhejiang Cancer Hospital
Sponsor institution
Source ClinicalTrials.gov