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A prospective, observational, one arm clinical study of camrelizumab (SHR-1210) combined with SOX regimen for postoperative adjuvant treatment of gastroesophageal junction cancer

A prospective, observational, one arm clinical study of camrelizumab (SHR-1210) combined with SOX regimen for postoperative adjuvant treatment of gastroesophageal junction cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046238
Enrollment
Unknown
Registered
2021-05-12
Start date
2021-05-12
Completion date
Unknown
Last updated
2021-12-21

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

Conditions

gastric cancer

Interventions

experimental group:Camrelizumab + S1+ oxaliplatin

Sponsors

The Second Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years, male or female; 2. Radical gastrectomy with R0 resection has been performed; 3. ECoG PS score 0-1; 4. The expected survival time is more than or equal to 6 months; 5. The function of main organs was normal, and there was no severe abnormal blood, heart, lung, liver, kidney, bone marrow and immune deficiency. The laboratory examination meets the following requirements: (1) Hemoglobin (HB) >=90 g / L; (2) WBC >=3.0x10^9/L Neutrophil count (neut) >=1.5x10^9/L (3) Platelet count (PLT) >=100x10^9/L (4) Liver function (AST or ALT) level <=2.5 ULN; Renal function (SCR) level <=1.5 ULN; (5) Total bilirubin (TBIL) <=1.5 ULN; (6) Urinary protein and occult blood were less than 2 +; Fecal occult blood < 2 +. 6. The subjects voluntarily joined the study, signed informed consent, good compliance, and cooperated with the follow-up; 7. Researchers believe that treatment can benefit.

Exclusion criteria

Exclusion criteria: 1. Those who have been proved to be allergic to the test drug and / or its excipients; 2. Subjects who have received or are receiving additional chemotherapy, radiotherapy, targeted or immunotherapy; 3. Have any active autoimmune disease or history of autoimmune disease; 4. Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >= 500 IU / ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method), or co infection of hepatitis B and hepatitis C; Or history of organ transplantation; 5. There are not well controlled clinical symptoms or diseases of heart, such as: (1) heart failure of NYHA grade 2 or above; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year. 6. Pregnant or lactating women; 7. According to the judgment of the researcher, the patients are not suitable for inclusion in this study; 8. Postoperative pathology showed positive margin; 9. Patients with lymph node metastasis; 10. Patients with systemic diseases and psychiatric diseases not suitable for chemotherapy; 11. Patients with acute infection need antibiotic treatment; 12. Patients who participated in clinical trials of other drugs within four weeks.

Design outcomes

Primary

MeasureTime frame
disease free survival;

Countries

China

Contacts

Public ContactZhou Lianbang

The Second Affiliated Hospital of Anhui Medical University

zhoulianbang@163.com+86 15156060699

Outcome results

None listed

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