Metastatic Esophageal Squamous Cell Carcinoma Clinical Trial
Official title:
A Multicenter, Phase II Clinical Study of AK104 (Anti-PD-1/CTLA-4 Bispecific Antibody) Alone or in Combination With Chemotherapy in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma
This is a two-arm, open, multicenter clinical study to evaluate the efficacy and safety of AK104 alone or in combination with cisplatin and paclitaxel in the treatment of advanced esophageal squamous carcinoma without systemic therapy.
During the treatment, eligible patients in cohort A with PD-L1 CPS ≥5 will receive AK104 10 mg/kg, intravenously, every 3 weeks (maximum 24 months of dosing); in cohort B, regardless of PD-L1 expression, eligible patients will receive AK104 10 mg/kg, intravenously, every 3 weeks (maximum 24 months of dosing), in combination with cisplatin (75 mg/m2) and paclitaxel (175 mg/m2), Q3W (up to 6 cycles, the specific cycles will be determined by the investigator). Thereafter, AK104 maintenance therapy will be continued until disease progression, intolerable toxicity, withdrawal of informed consent, death, or end of the study, whichever occurred first (maximum duration of treatment with AK104 should be less than 12 months). When patients with initially unresectable disease transformed into resectable, an operation can be considered and the original regimen may be used after surgery. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT01142388 -
Paclitaxel With or Without Cixutumumab as Second-Line Therapy in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
|
Phase 2 | |
| Recruiting |
NCT06138028 -
Sintilimab and Chemotherapy Sequential Radiotherapy in Advanced Esophageal Cancer
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05512520 -
Concurrent Chemoradiotherapy for Stage IVB Esophageal Squamous Cell Carcinoma（EC-CRT-003）
|
Phase 2 | |
| Active, not recruiting |
NCT05142709 -
Real-world Experience of ICIs Plus Chemotherapy for Advanced ESCC.
|
||
| Completed |
NCT06190652 -
Real-world Experience of ICIs Plus Chemotherapy With or Without Radiotherapy for Advanced ESCC.
|
||
| Completed |
NCT01472419 -
Prognostic Factor Analysis in Metastatic Esophageal Squamous Cell Carcinoma
|
N/A | |
| Enrolling by invitation |
NCT03800953 -
The Ave-CRT Study for Newly Diagnosed Metastatic Esophageal Squamous Cell Carcinoma
|
Phase 2 | |
| Recruiting |
NCT06265285 -
Comparison of In-Home Versus In-Clinic Administration of Subcutaneous Nivolumab Through Cancer CARE (Connected Access and Remote Expertise) Beyond Walls (CCBW) Program
|
Phase 2 | |
| Recruiting |
NCT04949256 -
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)
|
Phase 3 | |
| Recruiting |
NCT05978193 -
Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma
|
Phase 2 | |
| Recruiting |
NCT05760391 -
A Study of IO Plus Radiotherapy in Patients With Advanced ESCC.
|
N/A | |
| Active, not recruiting |
NCT04460937 -
Testing the Addition of an Anti-cancer Drug, Adavosertib, to Radiation Therapy for Patients With Incurable Esophageal and Gastroesophageal Junction Cancers
|
Phase 1 |