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Efficacy and safety of irinotecan combined with retitroxel regimen in salvage chemotherapy for advanced esophageal squamous cell carcinoma

Efficacy and safety of irinotecan combined with retitroxel regimen in salvage chemotherapy for advanced esophageal squamous cell carcinoma

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027159
Enrollment
Unknown
Registered
2019-11-02
Start date
2019-11-01
Completion date
Unknown
Last updated
2019-11-04

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

Conditions

Advanced esophageal squamous cell cancer

Interventions

Experimental group:Irinotecan plus raltitrexed

Sponsors

The First People's Hospital of Yancheng City, Jiangsu Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed advanced esophageal squamous cell carcinoma; 2. Received chemotherapy including Taxanes, platinum, or fluorouracil aged between 20 and 80 years; 3. Irinotecan and letitrexed have not been used before; 4. Easurable or assessable lesions by imaging studies according to the RECIST guidelin; 5. Eastern Cooperative Oncology Group (ECOG) performance status score less than 3;) 6. Hematology, biochemistry and organ function: (1) Adequate bone marrow function (hemoglobin level >= 90 g/L, (2) White blood cell count of 4-10x10^9/L, neutrophil count >= 1.5x10^9/L, (3) Platelet count >= 100x10^9/L); (4) Hepatic function (total bilirubin = 60 ml/min 7. Estimated life expectancy more than 3 months.

Exclusion criteria

Exclusion criteria: 1. Preexisted peripheral toxicity >= grade 2 of the National Cancer Institute Common Toxicity Criteria; 2. Central nervous system metastases; 3. Concurrent treatment that interfered with the study evaluation; 4. Acute infection; 5. Other uncontrolled underlying medical conditions that would impair the ability of the patients to receive the planned treatment; 6. Pregnant, and breastfeeding women or women of child-bearing potential without adequate contraception; 7. With other secondary malignant tumors; 8. Other incompatible cases considered by the researchers.

Design outcomes

Primary

MeasureTime frame
PFS;OS;

Countries

China

Contacts

Public ContactDai Xichao

The First People's Hospital of Yancheng City, Jiangsu Province

rosefor1110@163.com+86 15851087216

Outcome results

None listed

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