A Multicenter Phase II Clinical Study of Neoadjuvant Use of Camrelizumab in Combination With Chemotherapy for Organ Preservation in Esophageal Cancer

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT06869226
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab + Nab-paclitaxel + Cisplatin — DRUG
    Three cycles of neoadjuvant therapy with camrelizumab (200 mg/dose D1, IV, Q3W)+Nab-paclitaxel(260 mg/m2 D1，IV，Q3W)+Cisplatin(75 mg/m2 D1，IV，Q3W); for patients with organ preservation intent entered into the watchful waiting strategy group and received radiotherapy (50.4 Gy/28 doses), with camrelizumab maintenance therapy for 4-12 weeks after the end of radiotherapy, and a total of up to one year of camrelizumab.

Study Details

This is a multicenter phase II clinical study to explore the efficacy, safety, and organ preservation feasibility of camrelizumab in combination with chemotherapy for resectable esophageal squamous carcinoma in patients with histologically and pathologically confirmed resectable esophageal squamous carcinoma.

Key Dates

Start date
Apr 30, 2025
Status verified
Mar 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
283 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab+chemotherapy

Primary Outcome Measure

Event-free survival (EFS) [ Time Frame: about 2 years ]

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