A Phase I/II Multicenter Study Evaluating the Efficacy and Safety of Induction Immunochemotherapy Followed by Concurrent Immuno-Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Cancer(SCR-ESCC-02)

Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

SCR-ESCC-02 is a multicenter, phase I/II clinical study to investigate the safety and efficacy of induction immunochemotherapy followed by concurrent chemoradiotherapy with anti-PD-1 therapy in patients diagnosed with locally advanced, unresectable esophageal cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Age between 18 and 75 years.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

• Clinical stage meeting the criteria of T1N+M0 or T2-4aN0-3M0 based on the 8th UICC-TNM classification.

• Ineligibility for surgical resections due to patients' unwillingness for surgery, technically unresectable disease, or being medically unfit for surgery.

• No prior anti-tumor treatment, including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy.

• Adequate hematological, pulmonary, cardiac, hepatic, renal, and thyroid function.

• Willingness to use contraception with an adequate method throughout the study.

• Documented informed consent.

Locations
Other Locations
China
Shanghai Chest Hospital
RECRUITING
Shanghai
Contact Information
Primary
Wen Yu, M.D
yuzhiwen0827@163.com
021-22200000-3203
Time Frame
Start Date: 2023-01-10
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 50
Treatments
Experimental: IC+ICRT group
2 cycles of PD-1 inhibitor + nab-paclitaxel + cisplatin followed by concurrent PD-1 inhibitor + radiotherapy (45-50Gy/25fx) + nab-paclitaxel + cisplatin
Related Therapeutic Areas
Sponsors
Leads: Shanghai Chest Hospital

This content was sourced from clinicaltrials.gov

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