NCT07016724 Neoadjuvant Radiochemotherapy Combined With Cadonilizumab for Local Advanced Esophageal Squamous Cell Cancer
| NCT ID | NCT07016724 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital of Zhengzhou University |
| Condition | Esophageal Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 208 participants |
| Start Date | 2024-08-15 |
| Primary Completion | 2026-08-31 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 208 participants in total. It began in 2024-08-15 with a primary completion date of 2026-08-31.
⚠ 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 squamous cell cancer (ESCC) has a high incidence in China. Although the fast development of immune check point inhibitors (ICIs), the rate of pCR is limited with the mode of ICIs combined with neoadjuvant radiochemotherapy. The rate of pCR under ICIs combined with neoadjuvant radiochemotherapy was reported around 50%, which means more than half of those patients could not obtain pCR in reality. In order to explore a more effective mode of neoadjuvant therapy for ESCC, we designed this study to evaluate the effect of PD-1/CTLA-4 bi-antibody, termed as cadonilizumab, combined with neoadjuvant radiochemotherapy in local advanced ESCC.
Eligibility Criteria
Inclusion Criteria: * diagnosed with esophageal squamous cell cancer; * staged with cT1N+M0/cT2-3N0-3M0; * experienced no cancer-related treatment; * ECOG 0-1; * Expected survival more than 6 months; * aimed at neoadjuvant therapy for surger; * have adquate organ function. Exclusion Criteria: * diagnosed with other types of cancer during last five years; * have a tendency to bleed; * accepted any type of cancer-related therapy.
Contact & Investigator
Xiangbo Wan
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital of Zhengzhou University
Frequently Asked Questions
Who can join the NCT07016724 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Esophageal Squamous Cell Carcinoma. 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 NCT07016724 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07016724 currently recruiting?
Yes, NCT07016724 is actively recruiting participants. Contact the research team at wanxbo@zzu.edu.cn for enrollment information.
Where is the NCT07016724 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT07016724 clinical trial?
NCT07016724 is sponsored by The First Affiliated Hospital of Zhengzhou University. The principal investigator is Xiangbo Wan at The First Affiliated Hospital of Zhengzhou University. The trial plans to enroll 208 participants.