RecruitingPhase 3NCT06339060

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.


Sponsor

Ruijin Hospital

Enrollment

356 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study, called PALACE3, looks at whether patients with esophageal (food pipe) cancer who respond well to a combination of chemotherapy, radiation, and immunotherapy might be able to avoid surgery while still achieving excellent cancer control. It is testing an "organ-preserving" strategy. **You may be eligible if...** - You have been diagnosed with resectable esophageal squamous cell cancer (a specific type of esophageal cancer confirmed by biopsy) - Your cancer is locally advanced but has not spread to distant organs - Your ECOG performance status is 0 or 1 (you are active and able to carry out daily activities) - You are willing to sign the consent form **You may NOT be eligible if...** - You have an active autoimmune disease or history of autoimmune disease - You need long-term steroids or other immune-suppressing medications - You have a history of symptomatic interstitial lung disease (scarring of the lungs) - You are allergic to the study drugs - You are pregnant or breastfeeding - You have previously received chemotherapy, radiation, targeted therapy, or immunotherapy for this or any other cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTExperimental: 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_PRODUCTActive 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

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NCT06339060


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