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Clinical trial of PD-1 blockade after reduced-dose of oxaliplatin induction in neoadjuvant therapy for local advanced gastric cancer patient

Immune induction by reduced dose of oxaliplatin in gastric cancer to enhance the sensitivity to anti-PD-1 immunotherapy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037757
Enrollment
Unknown
Registered
2020-08-31
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-11-02

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:reduced SOX+anti-PD-1

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Aged 20-75 years old; (2) The pathological diagnosis of gastric cancer or gastroesophageal junction adenocarcinoma; the cancer is diagnosed as locally unresectable; (3) The ECOG score is 0-1 points; (4) The expected survival period >=24 weeks; (5) Able to swallow pills normally; (6) untreated for any anti-tumor drugs; (7) According to the RECIST 1.1 standard, there is at least one measurable lesion, and the lesion has not been irradiated; (8) No significant organ function decline.

Exclusion criteria

Exclusion criteria: (1) The patient has clinically significant uncontrollable intestinal, cardiovascular, and respiratory diseases; (2) Have received any anti-cancer treatment; (3) Have received growth factor and GCSF drug treatment before the first administration; (4) Female patients who are pregnant or breastfeeding; (5) The patient has any active autoimmune disease or a history of autoimmune disease; (6) The patient is using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive purposes; (7) Patients who have received hematopoietic stimulating factors, such as granulocyte colony stimulating factor (G-CSF), erythropoietin, etc. within 1 week before the first administration of the study drug.

Design outcomes

Primary

MeasureTime frame
ORR;R0 resection rate;3 year OS;

Secondary

MeasureTime frame
PFS;QOL;

Countries

China

Contacts

Public ContactJi Kun Li

Shanghai General Hospital

jkli65975@163.com+86 13386259836

Outcome results

None listed

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