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Prospective, multi-center, single-arm clinical study of carrelizumab combined with SOX regimen in neoadjuvant therapy for locally advanced gastric cancer

Prospective, multi-center, single-arm clinical study of carrelizumab combined with SOX regimen in neoadjuvant therapy for locally advanced gastric cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200058132
Enrollment
Unknown
Registered
2022-03-30
Start date
2022-03-30
Completion date
Unknown
Last updated
2023-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric cancer

Interventions

Intervention Group:Carrelizumab combined with Sox regimen

Sponsors

The First Affiliated Hospital of USTC WEST district
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-75 years old, male or female; 2.ECOG score is less than or equal to 1; 3. Patients with pathologically and/or cytologically confirmed gastric cancer Gastric adenocarcinoma or gastric esophageal junction adenocarcinoma 4. Normal function of major organs; 5. Cardiac function was good before enrollment, no myocardial infarction occurred within half a year, hypertension and other coronary heart diseases were within the control range at present; 6. No other uncontrollable benign diseases such as lung, kidney and liver infection before enrollment; 7. Not participating in other clinical studies before and during treatment; 8. Women of childbearing age must have used a reliable contraceptive method or have performed a pregnancy test (serum or urine) within 7 days prior to enrollment with negative results and be willing to use an appropriate method of contraception during the trial period and 8 weeks after the last administration of the trial drug; 9. Subjects voluntarily joined the study, signed informed consent and cooperated with follow-up.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; Female patients of childbearing age and those who wanted to have children during the study; 2. Patients with POSITIVE HER-2 test and BRAF test; 3. Patients with contraindications for surgical treatment and chemotherapy or physical condition and organ function are not allowed to undergo large abdominal surgery; 4. Patients with hypertension (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg) suffering from grade I or above myocardial ischemia or myocardial infarction, arrhythmia and Grade II cardiac insufficiency; 5. Abnormal coagulation function (INR >1.5 or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 ULN), with bleeding tendency or receiving thrombolytic or anticoagulant therapy; 6. Patients with positive urine protein (urine protein test 2+ or above, or 24-hour urine protein quantification > 1.0g); 7. Those who had received other drug therapy before enrollment or could not be guaranteed to follow the study requirements after enrollment; He had previously undergone partial gastrectomy; 8. Drug allergy to this program.

Design outcomes

Primary

MeasureTime frame
The PCR rate;

Secondary

MeasureTime frame
overall survival;disease-free survival;R0 removal rate;

Countries

China

Contacts

Public ContactZhongliang Ning

The First Affiliated Hospital of USTC WEST district

nzl16382@163.com+86 13956951551

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026