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Clinical comparative study of neoadjuvant intraperitoneal chemotherapy based on paclitaxel for peritoneal metastasis of colorectal cancer

Clinical comparative study of neoadjuvant intraperitoneal chemotherapy based on paclitaxel for peritoneal metastasis of colorectal cancer

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036376
Enrollment
Unknown
Registered
2020-08-22
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-07

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

Conditions

Colorectal cancer

Interventions

Control group:Empirical systemic standard regimen neoadjuvant chemotherapy (FolFox)
Experimental group:Paclitaxel intraperitoneal chemotherapy combined with systemic standard regimen for neoadjuvant chemotherapy

Sponsors

Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Colorectal and peritoneal metastatic adenocarcinoma was confirmed by pathology; 2. Aged >=18 years old; 3. ECOG score 0-1; 4. Body Mass Index (BMI, Body Mass Index) 18-30kg/m2. 5. PCI score > 15 6. Before starting chemotherapy, the white blood cell and platelet count should not be lower than the lower limit of normal, and the creatinine and total bilirubin should not be higher than the upper limit of normal 7. Before the start of the study, the patient himself or the authorized client signed the informed consent form and agreed to be included in the study

Exclusion criteria

Exclusion criteria: 1. Those who have undergone CRS; 2. Patients with previous history of intraperitoneal chemotherapy; 3. Suffered from malignant tumors in the past 5 years, but excluding other skin malignancies other than malignant melanoma, cervical carcinoma in situ, and stage 1A endometrial cancer; 4. There were other metastasis except lymph node and peritoneum; 5. Pregnant or breastfeeding women; 6. Patients who have received neoadjuvant radiotherapy and chemotherapy; 7. Patients who are allergic to the drugs involved in the study; 8. Patients whose abdominal cavity has severe adhesions confirmed by surgery or other means and cannot undergo abdominal chemotherapy; 9. Patients whose life expectancy does not exceed 12 weeks; 10.Patients who were assessed to have contraindications to intraperitoneal chemotherapy; 11. Refusing to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
Overall Response Rate;progression-free survival, PFS;

Countries

China

Contacts

Public ContactJing Sun

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

sj11788@rjh.com.cn+86 13524284622

Outcome results

None listed

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