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Albumin-bound paclitaxel combined with lobaplatin-induced chemotherapy + albumin-bound paclitaxel combined with lobaplatin in the treatment of locally advanced esophageal cancer

Albumin-bound paclitaxel combined with lobaplatin-induced chemotherapy and sequential concurrent chemoradiotherapy for locally advanced esophageal cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025080
Enrollment
Unknown
Registered
2019-08-10
Start date
2019-09-05
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

Esophageal cancer

Interventions

experimental group:Induction chemotherapy followed by concurrent chemoradiotherapy

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients voluntarily participate , with good compliance, can complete observation and follow-up, and sign informed consent; 2. Histologically confrmed ESCC and classifed as advanced , no anti-tumor drugs other than test drugs in the past 4 weeks, and can receive specialist anti-tumor treatment; 3. At least one measurable lesion (CT examination diameter >= 1cm, other examination methods >= 2cm); 4. ECOG = 3000/µL, absolute count of neutrophils (ANC) >= 1500/µL, platelets >= 100,000/µL, hemoglobin >= 9.0g/dL; (2) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 times the upper limit of normal (ULN), alkaline phosphatase <= 4 times ULN, total bilirubin <= 1.5 times ULN; (3) Serum creatinine <= 1.5 times ULN, the blood urea nitrogen (BUN) <= 2.5 times ULN; (4) Prothrombin time international normalized ratio or partial thromboplastin time <= 1.5 times ULN; (5) Left ventricular ejection fraction (LVEF) greater than or equal to 60% as assessed by Doppler ultrasound; 9. Female: contraception during treatment and 6 months after treatment; non-lactation; male: birth control during the treatment period and within 6 months after the end of treatment.

Exclusion criteria

Exclusion criteria: 1. Pregnancy, lactation, or female patient with fertility without contraception; 2. Serious acute infections, suppurative and chronic infections, and wounds are hard to heal; 3. Esophageal perforation (patients with esophageal tracheal fistula or esophageal fistula), with obvious symptoms and multiple distant metastases; 4. Received other anti-tumor treatments within 4 weeks before enrollment; 5. Abnormal blood coagulation, bleeding tendency (such as active gastrointestinal ulcer) or symptomatic treatment of thrombolysis or anticoagulation; 6. With severe heart disease include: congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction within half a year, severe heart valve disease, and refractory hypertension; 7. Suffering from nervous, mental or mental disorders that are difficult to control, poor compliance, and inability to cooperate with and describe treatment responders; 8. Severe cirrhosis, severe renal insufficiency.

Design outcomes

Primary

MeasureTime frame
Progression free survival;

Secondary

MeasureTime frame
Objective response rate;Overall survival;Safety;Quality of Life;

Countries

China

Contacts

Public ContactLiu Fang

Chinese PLA General Hospital

liufangfsg@163.com+86 13520469875

Outcome results

None listed

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