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RECRUITINGPhase 3INTERVENTIONAL

An Organ Preservation Strategies After Chemoradiotherapy Combined With Immunotherapy for Esophageal Cancer (PALACE3).

An Organ Preservation Strategies After Chemoradiotherapy Combined With Immunotherapy for Esophageal Cancer vs Cross Therapy.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Patients with locally advanced esophageal squamous cell carcinoma will randomly assigned to receive neoadjuvant chemo-radiotherapy combined with immunotherapy post organ preservation strategy (experimental group) or neoadjuvant chemo-radiotherapy followed by surgery (control group). The 3-year overall survival rate is the primary outcome.

Who May Be Eligible (Plain English)

Who May Qualify: - A patient will be eligible for inclusion in this study only if ALL of the following criteria apply: - diagnosed by tissue sample (biopsy-confirmed) cT2-T4a,N0-N+,M0 resectable esophageal squamous cell carcinoma. - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Patients approve and sign the willing to sign a consent form Who Should NOT Join This Trial: - Patients with active autoimmune conditions (where your immune system attacks your own body) or history of autoimmune conditions (where your immune system attacks your own body). - Patients who have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications. - Subjects with a history of symptomatic interstitial lung disease. - History of allergy to study drug components. - Women must not be pregnant or breast-feeding. - Men with female partners (WOCBP) that are not willing to use contraception. - Patient has received prior chemotherapy, radiotherapy, target therapy and immune therapy for this malignancy or for any other past malignancy. - medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * A patient will be eligible for inclusion in this study only if ALL of the following criteria apply: * Histologically confirmed cT2-T4a,N0-N+,M0 resectable esophageal squamous cell carcinoma. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Patients approve and sign the informed consent Exclusion Criteria: * Patients with active autoimmune disease or history of autoimmune disease. * Patients who have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications. * Subjects with a history of symptomatic interstitial lung disease. * History of allergy to study drug components. * Women must not be pregnant or breast-feeding. * Men with female partners (WOCBP) that are not willing to use contraception. * Patient has received prior chemotherapy, radiotherapy, target therapy and immune therapy for this malignancy or for any other past malignancy. * medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events

Treatments Being Tested

COMBINATION_PRODUCT

Experimental: Arm 1 Organ preservation

Arm 1 patients will undergo clinical response evaluations (CREs) after neoadjuvant therapy(A+B+C), If cancer is detected, surgery will be performed. Patients with clinical complete response (cCR) are eligible for active surveillance where regular CREs are performed to detect regrowth of cancer.Postoperative adjuvant therapy will follow the NCCN guideline. A: Camrelizumab 200mg IV on days 1 and 22 B: Carboplatin (AUC=2) IV and Paclitaxel-albumin (50mg/m²) IV on day 1,8,15,22,29. C: Radiotherapy will start on day 1 of chemotherapy. A total of 41.4 Gy, 23 fractions of 1.8 Gy, 5 fractions a week. A+B+C=Neoadjuvant therapy

COMBINATION_PRODUCT

Active Comparator: Arm 2 Surgery

Arm 2 patients will undergo surgery after neoadjuvant therapy(B+C).Postoperative adjuvant therapy will follow the NCCN guideline. B: Carboplatin (AUC=2) IV and Paclitaxel-albumin (50mg/m²) IV on day 1,8,15,22,29. C: Radiotherapy will start on day 1 of chemotherapy. A total of 41.4 Gy, 23 fractions of 1.8 Gy, 5 fractions a week.

Locations (1)

Ruijin hospital
Shanghai, China