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

NCT06339060 | Recruiting Phase 3

• 1 other identifier: RTS-022
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Cancer

Keywords

Chemoradiotherapy; Immunotherapy; Organ preservation; Active surveillance

Outcome Measures

Primary Outcomes (1)

• 3-year overall survival rate

  The proportion of patients who survived within 3 years from randomization

  From date of randomization until the date of death from any cause，up to 5 years

Study Arms (2)

Arm1 Organ preservation

EXPERIMENTAL

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.

Combination Product: Experimental: Arm 1 Organ preservation

Arm 2 Surgery

ACTIVE COMPARATOR

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.

Combination Product: Active Comparator: Arm 2 Surgery

Interventions

Experimental: Arm 1 Organ preservation COMBINATION_PRODUCT

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

Arm1 Organ preservation

Active Comparator: Arm 2 Surgery COMBINATION_PRODUCT

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.

Arm 2 Surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Hecheng Li, MD/PHD

  Ruijin Hospital Shanghaijiaotong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hecheng Li

CONTACT

19121652450; lihecheng2000@hotmail.com

Chengqiang Li

CONTACT

13524282905; lcq12305@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomize patients who meet the inclusion criteria Grouping, randomly assigned to the experimental group in a 1:1 ratio (organ preservation strategy after neoadjuvant chemotherapy combined with immunotherapy) And the control group (limited time for esophageal cancer radical surgery after neoadjuvant radiotherapy and chemotherapy)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: April 1, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 3, 2024

Record last verified: 2024-06

Locations

CN (1)