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New treatment option for Esophageal Squamous Cell Carcinoma
Official title Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC
ClinicalTrials.gov ID: NCT05775419
What this study is testing
What is Consolidation chemotherapy (4 courses)?
Consolidation chemotherapy (4 courses) is an investigational medicine, being studied as a potential treatment for esophageal squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a phase III, multicenter, prospective randomized controlled clinical study comparing the efficacy of non-surgical esophageal squamous cell carcinoma with radical chemoradiotherapy and radical chemoradiotherapy combined with consolidation chemotherapy. The survival time and side effects of patients were observed and compared.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age 18-70 years old, not limited to male or female; at least able to take liquid diet;
- Esophageal squamous cell carcinoma proved by histopathology;
- Esophageal squamous cell carcinoma that is inoperable or refuses surgery,
- According to the 2017 8th edition of AJCC esophageal cancer new staging criteria, the tumor is T2N0M0-TxNxM0 stage;
- ECOG 0-1; life expectancy \> 6 months;
You likely can't join if
- History of malignant tumors in other parts;
- Duplicate carcinoma of the esophagus;
- Pregnant or lactating patients;
- Fertility but not using contraceptive measures;
- Serious comorbidities: very high-risk hypertension, severe pulmonary function impairment, massive myocardial infarction, cardiac function ≥ grade II...
- During the active period of infectious diseases;
See the full eligibility criteria
- Age 18-70 years old, not limited to male or female; at least able to take liquid diet;
- Esophageal squamous cell carcinoma proved by histopathology;
- Esophageal squamous cell carcinoma that is inoperable or refuses surgery,
- According to the 2017 8th edition of AJCC esophageal cancer new staging criteria, the tumor is T2N0M0-TxNxM0 stage;
- ECOG 0-1; life expectancy \> 6 months;
- No chemotherapy was used before selection;
- No history of radiotherapy;
- No surgical treatment;
- No serious allergic history;
- Hemoglobin 100 g/L, WBC3.5109/L, neutrophils 1.5109, platelets 100109/L; CR1.5 upper limit of normal, TB2.5 upper limit of normal, AST and ALT2.5 upper normal limit, AKP2.5 upper normal limit ; Be able to understand the...
- History of malignant tumors in other parts;
- Duplicate carcinoma of the esophagus;
- Pregnant or lactating patients;
- Fertility but not using contraceptive measures;
- Serious comorbidities: very high-risk hypertension, severe pulmonary function impairment, massive myocardial infarction, cardiac function ≥ grade II, mental history and severe diabetes;
- During the active period of infectious diseases;
- Participate in other clinical trials at present or within four weeks before enrollment;
- Simultaneous treatment with other anti-cancer drugs (including anti-cancer traditional Chinese medicine);
- After esophageal stent placement;
- Cases with perforation tendency;
- Have a history of organ transplantation.
- Widespread metastases throughout the body, including lung, liver, bone, and intracranial metastases;
- Known or suspected allergic to chemotherapy drugs; According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the...
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.