Advanced or metastatic gastric cancer or gastroesophageal junction cancer
Conditions
Interventions
QL1706 + SOX:QL1706 combined with chemotherapy
Sponsors
Beijing Friendship Hospital ,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary participation in the clinical study;full understanding and informed consent to the study (ICF);willingness and ability to complete all trial procedures; 2. Age 18-80 years, gender not limited; 3. Patients confirmed by imaging examinations to have locally advanced unresectable, recurrent unresectable, or metastatic gastric or gastroesophageal junction cancer, and histopathological confirmation of adenocarcinoma; 4. Provision of a negative HER2 overexpression or amplification report;HER2 overexpression or amplification negative is defined as IHC 0/1+, or IHC 2+ and FISH/ISH negative; 5. No prior systemic therapy (including anti-HER-2 therapy) for advanced or metastatic GC/GEJC. For patients who have previously received adjuvant or neoadjuvant therapy for GC/GEJC (including chemotherapy, radiotherapy, or chemoradiotherapy), the time between the first recurrence or disease progression and the end of the last treatment is greater than 6 months. Subjects are permitted to have previously received anti-tumor traditional Chinese medicine preparations, but must have discontinued them at least 2 weeks prior to admission; 6.ECOG performance status score of 0-1; 7. Must have at least one measurable lesion as defined by RECIST v1.1; 8. All acute toxicities resulting from previous anti-tumor treatment or surgery must have resolved to grade 0-1 (according to NCI CTCAE version 5.0) or to the level specified in the inclusion/exclusion criteria. Excluding other toxicities such as hair loss, fatigue, and hearing impairment that researchers deem not pose a safety risk to subjects; 9. Organ function requirements (laboratory tests within 7 days prior to treatment): Complete blood count (no blood transfusion, no use of granulocyte colony-stimulating factor [G-CSF], no medication correction within 14 days prior to screening): White blood cell count (WBC) >= 3,000/mm3 (3.0 × 10^9/L); Neutral cell count (ANC) >= 1,500/mm3 (1.5 × 10^9/L);Platelet count (PLT) >= 100,000/mm3 (100 × 10^9/L);Hemoglobin (Hb) >= 9.0 g/dL (90 g/L); Biochemical tests (no albumin infusion within 14 days prior to screening): Albumin >= 3.0 g/dL (30 g/L);Cretin = 50 ml/min (calculated using the Cockcroft-Gault formula);total bilirubin (BIL) = 2+, then 24-hour urine protein quantification must show protein = 3 months; 11. For premenopausal women of childbearing potential, 7 days prior to starting treatment is required. A serum or urine pregnancy test must be performed within 3 days, and the result must be negative. The patient must not be breastfeeding. All enrolled patients should use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.
Exclusion criteria
Exclusion criteria: 1. Known as squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer, or adenocarcinoma mixed with other histological types of gastric cancer; 2. Having an active malignant tumor within the previous 2 years, other than the tumor the subject had at the time of enrollment in the study. Subjects with locally curable cancer (manifested as cured), such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ, are not excluded; 3. Subjects who have previously participated in a study of the investigational drug, received investigational treatment, or used an investigational device within 4 weeks prior to first dosing; 4. Subjects enrolled in another clinical study, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study (defined as more than 4 weeks between the first dosing and the last dosing in the previous clinical study or more than 5 half-lives of the investigational drug); 5. Subjects with untreated central nervous system (CNS) metastases, or uncontrolled or symptomatic active CNS metastases, which may manifest as clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, pia mater disease, and/or rapid progression. Students with adequately treated CNS metastases and whose neurological symptoms have returned to baseline levels at least 4 weeks prior to enrollment (excluding residual signs or symptoms related to CNS treatment) are eligible for enrollment. In addition, subjects must have discontinued corticosteroids or received a stable or gradually decreasing dose of prednisone (or an equivalent dose of another corticosteroid) at least 4 weeks prior to enrollment; 6. Pleural effusion or ascites that could not be controlled by puncture drainage or other treatments within 14 days prior to enrollment;or moderate or greater pericardial effusion with clinical symptoms; 7.Weight loss of more than 20% within 2 months prior to enrollment; 8. Received the following treatments or medications prior to enrollment: Underwent major surgery within 28 days prior to enrollment (tissue biopsy for diagnostic purposes and peripherally inserted central venous catheter (PICC)/port implantation are permitted); Used immunosuppressive drugs within 14 days prior to enrollment, excluding nasal sprays and inhaled corticosteroids or physiological doses of systemic corticosteroids (i.e., not exceeding 10 mg/day). (Prednisone or other corticosteroids at equivalent physiological doses); Received a live attenuated vaccine within 28 days prior to enrollment or planned to receive it during the study period and within 60 days after the end of study drug treatment; Received local antitumor treatment (such as radiotherapy or tumor embolization) within 28 days prior to enrollment; 9. Diagnosed with any other malignant tumor within 5 years prior to enrollment, except for basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, intraductal carcinoma in situ of the breast, and papillary thyroid carcinoma with a clear medical record of cure, which can be treated locally; 10. Presence of any active, known, or suspected autoimmune disease. Subjects in a stable state who do not require systemic immunosuppressive therapy are eligible for enrollment, such as those with type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year progression - free survival rate;PFS;AEs;OS;DCR;1-year overall survival rate; | — |
Countries
China
Contacts
Public ContactWei Deng
Beijing Friendship Hospital ,Capital Medical University
Outcome results
None listed