Clinical trial · Interventional
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.
NCT06339060CI-TRIAL-00078496PALACE3recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Comparator: Arm 2 Surgery | Combination Product | — | UNRESOLVED |
| Experimental: Arm 1 Organ preservation | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm1 Organ preservation
- description
- 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 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.
- interventionNames
- Combination Product: Experimental: Arm 1 Organ preservation
- type
- ACTIVE_COMPARATOR
- label
- Arm 2 Surgery
- description
- 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. Oesophagectomy will be offered to patients without contraindication.Postoperative adjuvant therapy will follow the NCCN guideline.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.