Trial Title:
Radiotherapy in Patients With Metastatic Esophageal Cancer Responding to PD-1 Inhibitor Plus Chemotherapy
NCT ID:
NCT06084897
Condition:
Esophageal Neoplasm Metastatic
Esophageal Cancer Stage IVb
Conditions: Official terms:
Esophageal Neoplasms
Paclitaxel
Cisplatin
Carboplatin
Immune Checkpoint Inhibitors
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TP (Paclitaxel with cisplatin or carboplatin) or PF (Fluoropyrimidine with cisplatin or carboplatin) regimen depended on investigator's choice.
Description:
A maximum of six cycles was recommended for chemotherapy.
- Fluoropyrimidine (fluorouracil or capecitabine) with carboplatin or cisplatin;
- Paclitaxel (or Albumin-bound paclitaxel) with carboplatin or cisplatin.
Arm group label:
Consolidation radiotherapy
Arm group label:
Salvage radiotherapy
Other name:
Chemotherapy
Intervention type:
Biological
Intervention name:
PD-1 inhibitor
Description:
Nivolumab or Pembrolizumab or Tislelizumab or Serplulimab or Toripalimab or Sintilimab or
Camrelizumab
Arm group label:
Consolidation radiotherapy
Arm group label:
Salvage radiotherapy
Other name:
Immunotherapy
Intervention type:
Radiation
Intervention name:
Consolidation 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 49.22Gy/23f or
50Gy/25f to PGTV for lymphnode metastasis only patients and 40.66Gy/19f or 40Gy/20f for
organ metastasis patients. Radiation treatment is planned after chemotherapy completed.
Arm group label:
Consolidation radiotherapy
Other name:
Planned Radiotherapy
Intervention type:
Radiation
Intervention name:
Salvage 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 49.22Gy/23f or
50Gy/25f to PGTV for lymphnode metastasis only patients and 40.66~49.22Gy/19f ~23f or
40~50Gy/20~25f for organ metastasis patients. Radiation treatment is planned after
disease progression when recommended by multidisciplinary team.
Arm group label:
Salvage radiotherapy
Other name:
Radiotherapy when needed
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 II
clinical trial to assess whether radiotherapy could further improve the survival of
patients with metastatic esophageal cancer responding to PD-1 Inhibitor plus
chemotherapy.
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
metastatic EC.
As reported, for the patients with metastatic lung cancer or EC, locoregional
radiotherapy could improve survival, especially in those who responding to systemic
therapy. 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 those patients with
metastatic EC responding to systemic therapy improve local control, relieve the local
symptoms, and even improve survival.
Therefore, the investigators intend to conduct a prospective, multicenter phase II trial
to assess the efficiency and safety of radiotherapy with chemotherapy and immunotherapy
for 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 AJCC Cancer Staging Manual, 8th
Edition) or recurrent patients with recurrence after radical treatment (radical
treatment includes surgery and radiotherapy, but the recurrence site cannot be
located in the previous radiotherapy field).
-
3. ECOG performance 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.For patients after definitive or preoperative radiotherapy, no recurrence was in
the prior radiation filed;
- 6.Expected survival is more than 12 weeks;
- 7.Informed consent provided;
- 8.With response to 2-4 cycles of the first-line chemotherapy combined with
immunotherapy.
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:
October 16, 2023
Completion date:
October 26, 2028
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:
Hebei Medical University Fourth Hospital
Agency class:
Other
Collaborator:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Collaborator:
Agency:
Anyang Tumor 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/NCT06084897
