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New treatment option for Esophageal Neoplasm Metastatic
Official title Radiotherapy in Patients With Metastatic Esophageal Cancer Responding to PD-1 Inhibitor Plus Chemotherapy
ClinicalTrials.gov ID: NCT06084897
What this study is testing
What is TP (Paclitaxel with cisplatin or carboplatin) or PF (Fluoropyrimidine with cisplatin or carboplatin) regimen depended on investigator's choice.?
TP (Paclitaxel with cisplatin or carboplatin) or PF (Fluoropyrimidine with cisplatin or carboplatin) regimen depended on investigator's choice. is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for esophageal neoplasm metastatic.
Also referred to as Chemotherapy.
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
- The treatment efficacy for stage IVb esophageal cancer has been improved through chemotherapy combined with immunotherapy recently. On this basis, the investigators intend to conduct a prospective, multicenter phase II clinical trial to assess whether radiotherapy could further improve the survival of patients with metastatic esophageal cancer responding to PD-1 Inhibitor plus chemotherapy.
- Phase 2: a mid-size study of how well it works
- 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 and older
You may be able to join if
- 1\. ≥18 years, any gender
- 2\. Histologically or cytologically confirmed squamous cell carcinoma of esophageal cancer. The initial clinical stage is IVb (2018 AJCC Cancer...
- 3\. ECOG performance status \<= 1. Patients aged 65 years and over need to complete G8 screening or Comprehensive Geriatric Assessment, and the final...
- 4.There was no significant abnormality in laboratory routine indicators such as blood routine and liver and kidney function;
- 5.For patients after definitive or preoperative radiotherapy, no recurrence was in the prior radiation filed;
You likely can't join if
- 1.Patients with other cancer history except hypopharyngeal carcinoma in situ, non-malignant skin cancer and cervical carcinoma in situ.
- 2.Received surgery (except ostomy), chemotherapy or other anti-tumor treatment before enrollment；
- 3\. Active infection currently exists . The following conditions occurred within 6 months before randomization: myocardial infarction...
- 4\. History of allergy to chemotherapy drugs or autoimmune disease;
- 5\. Participate in other clinical trials at present or within 4 weeks before enrollment;
- 6.There are factors such as high risk of fistula that radiotherapy cannot be safely carried out as assessed by the radiation oncologist.
See the full eligibility criteria
- 1\. ≥18 years, any gender
- 2\. Histologically or cytologically confirmed squamous cell carcinoma of esophageal cancer. The initial clinical stage is IVb (2018 AJCC Cancer Staging Manual, 8th Edition) or recurrent patients with recurrence after...
- 3\. ECOG performance status \<= 1. Patients aged 65 years and over need to complete G8 screening or Comprehensive Geriatric Assessment, and the final evaluation is good;
- 4.There was no significant abnormality in laboratory routine indicators such as blood routine and liver and kidney function;
- 5.For patients after definitive or preoperative radiotherapy, no recurrence was in the prior radiation filed;
- 6.Expected survival is more than 12 weeks;
- 7.Informed consent provided;
- 8.With response to 2-4 cycles of the first-line chemotherapy combined with immunotherapy.
- 1.Patients with other cancer history except hypopharyngeal carcinoma in situ, non-malignant skin cancer and cervical carcinoma in situ.
- 2.Received surgery (except ostomy), chemotherapy or other anti-tumor treatment before enrollment；
- 3\. Active infection currently exists . The following conditions occurred within 6 months before randomization: myocardial infarction, cerebrovascular accident, or received gastrointestinal, neurological...
- 4\. History of allergy to chemotherapy drugs or autoimmune disease;
- 5\. Participate in other clinical trials at present or within 4 weeks before enrollment;
- 6.There are factors such as high risk of fistula that radiotherapy cannot be safely carried out as assessed by the radiation oncologist.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, 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.