NCT04821843 Neoadjuvant Treatment Modalities in Esophageal Cancer
| NCT ID | NCT04821843 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Esophageal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2002-01-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 2,000 participants in total. It began in 2002-01-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Esophageal cancer is the most prevalent cancer globally with poor survival outcome. The prognosis with surgery alone is poor, accounting for 30-40% of overall survival at 5 year. Either neoadjuvant chemotherapy (nCT) or chemoradiotherapy (nCRT) has been shown as efficatious therapy to improve patients outcomes in esophageal or esophagogastric junction cancer as compared with surgery alone. The purpose of this study was to explore the optimal neoadjuvant treatment modalities including PD-1/PD-L1 antibody or targeted drug for patients with esophageal or esophagogastric junction cancer.
Eligibility Criteria
Inclusion Criteria: * ≥18 years； * Esophageal or Esophagogastric cancer； * Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as I-IVa (AJCC 8th)； * Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences； * ECOG PS score: 0\~1； * Estimated survival time ≥3 months； * Normal organ and marrow function as defined below:Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 4,000 G/L; Neutrophil: greater than or equal to 2,000 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml/min; AST/ALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit； * Informed consent； Exclusion Criteria: * With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc； * Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer； * Existing active infection such as active tuberculosis and hepatitis； * History of myocardial infarction within the past 6 months or history of ventricular arrhythmia； * Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness History of allergic reactions attributed to paclitaxel, albumin or cisplatin； * Participation in other clinical trials currently or within 4 weeks of selection； * Pregnant or lactating females； * Absence of medical records.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04821843 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04821843 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 2,000 participants.
Is NCT04821843 currently recruiting?
Yes, NCT04821843 is actively recruiting participants. Contact the research team at beryl_wx2000@163.com for enrollment information.
Where is the NCT04821843 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT04821843 clinical trial?
NCT04821843 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 2,000 participants.
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