Trials / Unknown
UnknownNCT04514835
A Phase Ⅱ Trials of Sintilimab as Consolidation Therapy After Radical Concurrent Chemoradiotherapy in Locally Advanced Unresectable ESCC
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- Sponsor
- The First Affiliated Hospital of Zhengzhou University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to observe and evaluate the efficacy and safety of Sintilimab for Consolidation Therapy After Radical Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
Detailed description
In China, the incidence of esophageal cancer has declined in recent years, but the mortality rate has been ranked fourth. Morbidity and mortality were ranked sixth and fourth in all malignancies, respectively. Therefore, esophageal cancer has always been a major malignant tumor that threatens the health of our residents.We designed a single-arm, open-label, phase II trial of Sintilimab for consolidation therapy after radical concurrent chemoradiotherapylocally advanced esophageal squamous cell carcinoma.The purpose of this study is to observe and evaluate the efficacy and safety of Sintilimab for consolidation therapy after radical concurrent chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cisplatin+Capecitabine+Sintilimab | The first stage:concurrent chemoradiotherapy，cisplatin，25-30mg/m2 ivgtt d1;capecitabine,800mg/m2, bid d1-5，qw，5weeks;concurrent radiotherapy,1.8-2Gy/d，5d/W，50-50.4Gy. second stage:Sintilimab, 200mg,q3w, a total of 3 times，Each infusion lasted for 30-60 min until disease progression or intolerable toxicity, with a maximum duration of no more than 12 months. |
Timeline
- Start date
- 2021-12-01
- Primary completion
- 2022-01-31
- Completion
- 2023-01-31
- First posted
- 2020-08-17
- Last updated
- 2021-08-25
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04514835. Inclusion in this directory is not an endorsement.