Using chemotherapy and immune therapy before endoscopic surgery for esophageal cancer
| ISRCTN | ISRCTN14125899 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14125899 |
- Submission date
- 26/01/2025
- Registration date
- 05/02/2025
- Last edited
- 05/02/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
In patients with advanced esophageal squamous cell carcinoma (ESCC), the combination of chemotherapy and immunotherapy has been shown to result in pathological complete response rates of approximately 32.4%. This study aims to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with immunotherapy followed by sequential endoscopic resection for patients with cT1bN0M0 ESCC.
Who can participate?
Patients aged over 18 years and under 75 years of age diagnosed with T1b stage ESCC and have no clear lymph node or distant metastasis detected by imaging examinations
What does the study involve?
The treatment regimen consists of three cycles of concurrent neoadjuvant chemotherapy and two cycles of immunotherapy. A post-treatment endoscopic assessment will be conducted within four weeks of the conclusion of neoadjuvant therapy. If the primary lesions showed a significant size reduction, the patient underwent endoscopic resection. The primary study endpoints are the safety and the rate of pathological complete response.
What are the possible benefits and risks of participating?
The greatest benefit for patients is through this study, which avoids undergoing surgical procedures and preserves the integrity of the esophageal organs. The main risk of the research is the complications caused by chemotherapy and immunotherapy.
Where is the study run from?
The Cancer Hospital of the Chinese Academy of Medical Sciences, China
When is the study starting and how long is it expected to run for?
September 2023 to December 2026
Who is funding the study?
The Cancer Hospital of the Chinese Academy of Medical Sciences, China
Who is the main contact?
Dr Lizhou Dou, ddx198707@163.com
Contact information
Public, Scientific, Principal Investigator
Chinese Academy of Medical Sciences & Peking Union Medical College
National Cancer Center/Cancer Hospital
Panjiayuannanli No 17, Chaoyang District
Beijing
100021
China
| Phone | +86 010-87788522 |
|---|---|
| ddx198707@163.com |
Study information
| Study design | Single-center interventional non-randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Treatment, Safety, Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | Efficacy and safety of neoadjuvant chemotherapy combined with immunotherapy followed by sequential endoscopic resection for cT1bNOMO esophageal cancer |
| Study objectives | This study evaluates the efficacy and safety of neoadjuvant chemotherapy combined with immunotherapy followed by endoscopic resection in patients with cT1bN0M0 esophageal cancer. This treatment regimen is an effective non-surgical option for patients with early-stage esophageal cancer, with the potential to improve their prognosis and quality of life. |
| Ethics approval(s) |
Approved 14/09/2023, Independent Ethics Committee of the National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College/National GCP Center for Anticancer Drugs (Panjiayuannanli No 17, Chaoyang District, Beijing, 100021, China; +86 010-87788495; cancergcp@163.com), ref: 23/388-4130 |
| Health condition(s) or problem(s) studied | The objective of this study is to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with immunotherapy followed by sequential endoscopic resection in patients with cT1bN0M0 esophageal cancer |
| Intervention | Patients with cT1bN0M0 esophageal cancer who meet the inclusion and exclusion criteria will receive 3 cycles of concurrent neoadjuvant chemotherapy (an albumin-bound intravenous infusion of paclitaxel 150 mg/m2 and an intravenous infusion of cisplatin 50 mg/m2 on day 1, and then every 2 weeks thereafter) and 2 cycles of immunotherapy (intravenous injection of panolizumab 200 mg on day 1 and then every 3 weeks thereafter) within 4 weeks of completing neoadjuvant therapy, followed by endoscopic evaluation. If the main lesions show a significant reduction from the pretreatment size, patients will undergo endoscopic resection within 6 weeks after completion of neoadjuvant therapy. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pathological complete response (pCR) measured using histopathological specimens after endoscopic resection |
| Secondary outcome measures | 1. Disease-free survival (DFS), defined as the time from resection to recurrence of tumor or death, measured using data collected in medical records at one time point 2. Overall survival (OS), defined as the time from study inclusion to death, measured using data collected in medical records at one time point |
| Overall study start date | 01/08/2023 |
| Completion date | 31/12/2031 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. Age ≥18 years, ≤75 years 2. Diagnosis of esophageal squamous cell carcinoma confirmed by biopsy according to at least one of the following criteria: 2.1. Lesion infiltration into the submucosa, as determined by combined gastroscopy and endoscopic ultrasound 2.2. No obvious lymph node metastasis or distant metastasis |
| Key exclusion criteria | 1. Esophageal adenocarcinoma and precancerous lesions 2. Current antiplatelet, anticoagulant, or thrombolytic therapy (such as with warfarin, heparin, clopidogrel, aspirin, streptokinase, and urokinase) 3. Myocardial infarction or other severe heart diseases in the past 6 months 4. Serious cerebrovascular diseases, such as cerebral hemorrhage and cerebral infarction, in the past 6 months 5. Previous surgery or chemotherapy and immunotherapy other than radiofrequency therapy, cryotherapy, photodynamic therapy, or ER due to esophageal tumors 6. Unmanaged mental illness and/or known drug or alcohol dependence that has not been cured, which limits the ability to understand or follow the instructions related to informed consent, post-treatment instructions or follow-up guidelines 7. Incomplete clinical data (ambiguous diagnosis, incomplete medical history, incomplete medication records, etc.) 8. Regional lymph node metastasis confirmed by imaging examination and needle biopsy 9. Signs of eosinophilic esophagitis found on endoscopic examination and/or histological examination 10. Grade C or D active reflux esophagitis 11. Allergy to platinum or paclitaxel 12. Pregnancy/lactation 13. Inability to provide signed informed consent |
| Date of first enrolment | 20/09/2023 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- China
Study participating centre
Beijing
100021
China
Sponsor information
Hospital/treatment centre
National Cancer Center/Cancer Hospital
Panjiayuannanli No 17, Chaoyang District
Beijing
100021
China
| Phone | +86 010-87788495 |
|---|---|
| cancergcp@163.com | |
| Website | http://www.cams.ac.cn/ |
"ROR" |
https://ror.org/02drdmm93 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Local government
- Alternative name(s)
- Cancer Institute and Hospital
- Location
- China
Results and Publications
| Intention to publish date | 31/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed in the current study be stored in a non-publicly available repository at the patient data records of the Cancer Hospital of the Chinese Academy of Medical Sciences |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 05/02/2025 | No | No |
Additional files
Editorial Notes
27/01/2025: Study's existence confirmed by the Independent Ethics Committee of the National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College/National GCP Center for Anticancer Drugs.
