Trial Title:
PD-1 Inhibitor Plus Chemotherapy With or Without Radiotherapy in Patients With Metastatic Esophageal Cancer
NCT ID:
NCT06086457
Condition:
Esophageal Neoplasms
Conditions: Official terms:
Esophageal Neoplasms
Immune Checkpoint Inhibitors
Conditions: Keywords:
Radiotherapy
PD-1 inhibitor
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Radiation
Description:
IMRT/VMAT technique. Patients receive radiotherapy once daily, 5 days a week for an
average of 5 weeks. Radiotherapy is delivered to achieve a dosage of 50Gy in 25 fractions
to planning gross tumor volume (PGTV) with involved site included.
Arm group label:
Radiotherapy arm
Other name:
Modern intensity modulated radiotherapy
Intervention type:
Drug
Intervention name:
TP or PF regimen depended on investigator's choice.
Description:
A maximum of six cycles was recommended for chemotherapy. Chemotherapy Regimen 1(TP
regimen A): Nab-paclitaxel(Albumin-bound paclitaxel) 110-130mg/ m2，d1，d8; Cisplatin
60-75mg/ m2，d1；Q3W； Chemotherapy Regimen 2 (TP regimen B): Paclitaxel 150-175 mg/m2, d1;
Cisplatin 60-75mg/ m2，d1；Q3W； PD-1 inhibitor 200mg, d1, Q3W Chemotherapy Regimen 3 (PF
regimen): Capecitabine 800mg/m2, bid, d1-14; Cisplatin 25-30mg/m2, d1,d2, Q3W.
Arm group label:
PD-1 inhibitor plus chemotherapy arm
Arm group label:
Radiotherapy arm
Other name:
Chemotherapy
Intervention type:
Biological
Intervention name:
PD-1 inhibitor
Description:
Camrelizumab (200mg, d1, Q3W) was continued until disease progression, unacceptable
toxicity, death, physician or patient decision to withdraw, non-compliance, or
discontinuation for administrative reasons (up to 35 cycles).
Arm group label:
PD-1 inhibitor plus chemotherapy arm
Arm group label:
Radiotherapy arm
Other name:
Camrelizumab
Summary:
The treatment efficacy for stage IVb esophageal cancer has been improved through
chemotherapy combined with immunotherapy recently.
On this basis, the investigators intend to conduct a prospective, multicenter phase III
clinical trial to assess whether radiotherapy with concurrent chemotherapy and
immunotherapy could further improve the survival of patients with metastatic esophageal
cancer.
Accompanied tissue samples, blood samples and urine samples will be analyzed by molecular
biological detection (Including Whole Exome Sequencing and proteomics) to explore
potential biomarkers for predicting outcomes, efficacy and toxicity.
Detailed description:
Esophageal cancer (EC) is one of the most common carcinomas with high morbidity and
mortality worldwide. More than 30% of the patients were stage IV when diagnosed.
Fluoropyrimidine plus platinum-based chemotherapy is recommended as first-line treatment
for patients with metastatic EC for approximately four decades, however, only minimal
improvement has been reached in overall survival (OS).
Recently, immune checkpoint inhibitors have shown effective antitumor activity in
patients with unresectable, advanced or metastatic EC. Several randomized trials have
demonstrated the PD-1 inhibitor could further improve the OS in patients with advanced
esophageal squamous cell carcinoma (ESCC) on the basis of chemotherapy. Chemotherapy
combined with immunotherapy has become one of the the standard treatment modality for
advanced EC.
As reported, for the patients with metastatic lung cancer or EC, locoregional
radiotherapy could improve survival. However, high-level evidence is still needed to
assess whether these patients can benefit from local radiotherapy.
The efficacy of immunotherapy combined with chemotherapy is obviously better than that of
chemotherapy alone. On this basis, locoregional radiotherapy may help some patients with
advanced EC improve local control, relieve the local symptoms and improving the quality
of life.
Therefore, the investigators intend to conduct a prospective, multicenter phase III trial
to assess the efficiency and safety of radiotherapy with chemotherapy and immunotherapy
of patients with metastatic EC. Accompanied tissue samples, blood samples and urine
samples will be analyzed by molecular biological detection to explore potential
biomarkers for predicting outcomes, efficacy and toxicity.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. ≥18 years, any gender
-
2. Histologically or cytologically confirmed squamous cell carcinoma of esophageal
cancer. The initial clinical stage is IVb (2018 American Joint Committee on
Cancer (AJCC) Cancer Staging Manual, 8th Edition) , with distant metastasis
involving no more than 2 organs (lymph node metastasis is counted);
-
3. ECOG (Eastern Cooperative Oncology Groupper) formance status <= 1. Patients
aged 65 years and over need to complete G8 screening or Comprehensive Geriatric
Assessment, and the final evaluation is good;
- 4.There was no significant abnormality in laboratory routine indicators such as
blood routine and liver and kidney function;
- 5.No prior history of thoracic radiation;
- 6.Expected survival is more than 12 weeks;
- 7.Informed consent provided.
Exclusion Criteria:
- 1.Patients with other cancer history except hypopharyngeal carcinoma in situ,
non-malignant skin cancer and cervical carcinoma in situ.
- 2.Received surgery (except ostomy), chemotherapy or other anti-tumor treatment
before enrollment；
-
3. Active infection currently exists . The following conditions occurred within 6
months before randomization: myocardial infarction, cerebrovascular accident,
or received gastrointestinal, neurological, cardiopulmonary surgery;
-
4. History of allergy to chemotherapy drugs or autoimmune disease;
-
5. Participate in other clinical trials at present or within 4 weeks before
enrollment;
- 6.There are factors such as high risk of fistula that radiotherapy cannot be safely
carried out as assessed by the radiation oncologist.
Gender:
All
Gender based:
Yes
Gender description:
gender identity
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer hospital, CAMS
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Wen-Yang Liu, MD
Email:
liuwenyang@cicams.ac.cn
Contact backup:
Phone ext:
Liu
Email:
liuwenyang@cicams.ac.cn
Investigator:
Last name:
Wen-Yang Liu
Email:
Principal Investigator
Start date:
February 4, 2024
Completion date:
August 28, 2029
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Collaborator:
Agency:
Beijing Cancer Prevention & Treatment Society
Agency class:
Other
Collaborator:
Agency:
Hebei Medical University Fourth Hospital
Agency class:
Other
Collaborator:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Collaborator:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Anyang Tumor Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Collaborator:
Agency:
Sichuan Cancer Hospital and Research Institute
Agency class:
Other
Collaborator:
Agency:
Tengzhou Central People's Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Xiamen University
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Zhengzhou University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
Second Affiliated Hospital of Xi'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
Affiliated Hospital of North Sichuan Medical College
Agency class:
Other
Collaborator:
Agency:
Changzhou Cancer Hospital of Soochow University
Agency class:
Other
Collaborator:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06086457
