Actively Recruiting
QL1706 Combined With SOX Used in Theperioperative Treatment
Led by Xiangdong Cheng · Updated on 2025-06-17
54
Participants Needed
1
Research Sites
327 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
QL1706 Combined With SOX Used in Theperioperative Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent to participate voluntarily
- Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
- Tumor stage at least T3 or node-positive, no distant metastasis (clinical stage 63T3 or N+, M0) confirmed by CT/MRI, including Siewert type II and III tumors
- Age between 18 and 75 years, male or female
- Eastern Cooperative Oncology Group performance status 0 or 1
- No prior anti-tumor treatment for gastric or gastroesophageal junction adenocarcinoma
- Planned surgical treatment after neoadjuvant therapy with expected R0 resection
- Expected survival of at least 6 months
- Normal function of major organs with specified blood counts, liver and kidney function, and coagulation parameters
- Negative pregnancy test for fertile female subjects within 72 hours before treatment start and use of effective contraception during the study and for 120 days after last dose
- Male subjects with fertile partners must use effective contraception during the study and for 120 days after last dose
- Good compliance and cooperation with follow-up
- Agreement to provide tumor tissue samples
You will not qualify if you...
- Tumor or other factors making surgery impossible or surgery refusal
- Previous or current treatment with radiation, chemotherapy, immune checkpoint inhibitors, or other anti-tumor drugs
- Use of immunosuppressive drugs or systemic hormones for immunosuppression within 2 weeks before starting the study
- Receipt of live attenuated vaccine within 4 weeks before starting the study or planned live vaccine during study or within 120 days after last dose
- Serious infections within 4 weeks before starting treatment or active pulmonary inflammation within 14 days
- Active autoimmune disease requiring systemic treatment within 2 years or history of autoimmune disease with possible recurrence
- History of immunodeficiency including HIV positive status or organ/bone marrow transplantation
- Poorly controlled heart conditions including heart failure NYHA grade II or above, unstable angina, recent myocardial infarction, significant arrhythmias, or prolonged QTc intervals
- Active or recent pulmonary tuberculosis infection
- Factors increasing risk of prolonged QTc or abnormal heart rate
- Active hepatitis B or C infection
- Peripheral neuropathy grade 2 or higher
- Other malignancies diagnosed within 5 years except certain low-risk cancers
- Known severe allergy to monoclonal antibodies or study drugs
- Deficiency of dihydropyrimidine dehydrogenase
- Upper gastrointestinal obstruction or malabsorption affecting drug absorption
- Pregnancy or breastfeeding
- Participation in another interventional clinical study unless observational or follow-up only
- Other serious medical conditions or factors affecting study safety or compliance according to investigator judgment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
X
Xiangdong Cheng
CONTACT
C
Can Hu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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