Study on the mechanism of Shenqi Fuzheng injection in reducing the side effects of perioperative intraperitoneal perfusion chemotherapy by improving intestinal flora

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400084293

Enrollment

Unknown

Registered

2024-05-14

Start date

2024-05-20

Completion date

Unknown

Last updated

2024-05-21

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

Conditions

Side effects after intraperitoneal perfusion chemotherapy during perioperative period of gastric cancer

Interventions

Experimental group:Intraperitoneal chemotherapy combined with intravenous Shenqi Fuzheng injection

Control group:Only intraoperative intraperitoneal chemotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Gastric cancer diagnosed by gastroscopy and pathological biopsy; 2) Preoperative clinical staging diagnosis, including abdominal enhanced CT and/or endoscopic ultrasound; 3) Patients with advanced gastric cancer; 4) Age =18 years old =80 years old; 5) ECOG=2, able to tolerate D2 lymphadenectomy; 6) No obvious chronic heart, liver, or kidney diseases, and no history of other malignant tumors; 7) Be able to comply with the protocol during the study and sign the informed consent; 8) Intraoperative intraperitoneal chemotherapy combined with intravenous Shenqi Fuzheng injection or intraoperative intraperitoneal chemotherapy alone.

Exclusion criteria

Exclusion criteria: 1) Multiple primary malignant tumors; 2) Intolerance to chemotherapy or allergy to chemotherapy drugs; 3)The primary tumor was not resected; 4) Patients who did not receive intraperitoneal chemotherapy; 5) Patients with undefined treatment options.

Design outcomes

Primary

Measure	Time frame
Humoral immunity and cellular immunity related indicators, such as IgA, IgG, CD4+, CD3 +, CD4+/CD8+, NK cells;	—

Secondary

Measure	Time frame
White blood cell (WBC), platelet (PLT), blood urea nitrogen (BUN), creatinine (Cr) and other blood routine and biochemical indicators;Adverse reactions mainly included nausea and vomiting, neurotoxicity, etc;European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(V3.0);European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Stomach 22;Hospital Anxiety and Depression Scale;Pittsburgh sleep quality index;TCM symptom scale for perioperative gastric cancer patients;The Revised Piper Fatigue Scale;	—

Measure

Time frame

White blood cell (WBC), platelet (PLT), blood urea nitrogen (BUN), creatinine (Cr) and other blood routine and biochemical indicators;Adverse reactions mainly included nausea and vomiting, neurotoxicity, etc;European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(V3.0);European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Stomach 22;Hospital Anxiety and Depression Scale;Pittsburgh sleep quality index;TCM symptom scale for perioperative gastric cancer patients;The Revised Piper Fatigue Scale;

—

Countries

China

Contacts

Public ContactYuxin Zhong

Cancer Hospital Chinese Academy of Medical Sciences

zhongyuxin@cicams.ac.cn+86 135 0108 7596

Outcome results

None listed

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