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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033338
Enrollment
Unknown
Registered
2020-05-28
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-06-01

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:Immunotherapy combined with Albumin-bound paclitaxel and lobaplatin-induced chemotherapy

Sponsors

The First Medical Center of PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The patients voluntarily participate in the research, have good compliance, can complete the observation and follow-up according to the test requirements, and sign the informed consent; 2. The patients with esophageal squamous cell carcinoma diagnosed by histopathology, whose clinical stage is advanced esophageal cancer, have not received other anti-tumor drugs other than the experimental drugs in the past 4 weeks, and can receive special anti-tumor treatment; 3. Patients with at least one measurable focus (CT diameter >= 1cm, other methods >= 2cm); 4. Patients with ECoG = 3000 / µ L, ANC absolute count > = 1500 / µ L, platelet > = 100000 / µ L, hemoglobin > = 9.0g/dl; (2) AST and ALT < = 2.5 times of upper limit of normal value (ULN), ALP < = 4 times of upper limit of normal value, total bilirubin < = 1.5 times of upper limit of normal value; (3) Serum creatinine < 1.5 times of ULN, blood urea nitrogen (BUN) < 2.5 times of ULN; (4) The international standard ratio of prothrombin time or partial thromboplastin time is less than 1.5 times of ULN; (5) The left ventricular ejection fraction (LVEF) was more than or equal to 60%; 9. Female: contraception during treatment and within 6 months after treatment; non lactation; male: avoiding childbearing during treatment and within 6 months after treatment.

Exclusion criteria

Exclusion criteria: 1. Pregnant, lactating and fertile women without contraceptive measures; 2. Patients with serious acute infection, suppurative and chronic infection, and the wound does not heal; 3. Patients with esophageal perforation (esophagotracheal fistula or those who may have esophagotracheal fistula) have obvious symptoms and multiple distant metastasis; 4. Patients who received other anti-tumor treatment within 4 weeks before admission; 5. Patients with abnormal coagulation, bleeding tendency (such as active peptic ulcer) or undergoing thrombolysis or anticoagulation; 6. the original serious heart disease, including: congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina, myocardial infarction within half a year, severe heart valve disease and stubborn hypertension; 7. Patients with uncontrollable neurological, mental diseases or mental disorders, poor compliance, unable to cooperate with and describe the treatment response; 8. Patients with severe cirrhosis and renal insufficiency.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
ORR;OS;

Countries

China

Contacts

Public ContactLiu Fang

The First Medical Center of PLA General Hospital

357278864@qq.com+86 18301071600

Outcome results

None listed

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