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Esophageal Squamous Cell Carcinoma

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Neoplasms, Squamous Cell

Esophageal Neoplasms

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Esophageal Cancer

Antineoplastic Agents

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Docetaxel

Nedaplatin

patients with R0 resected T≥3 or N≥1 thoracic esophageal squamous cell carcinoma began to receive chemotherapy of docetaxel combined with nedaplatin within 8 weeks after total two-field lymph node dissection. Docetaxel 75mg/m2 day 1, nedaplatin 75mg/m2 day 1, every 21 days for 4 cycles

patients with R0 resected T≥3 or N≥1 thoracic esophageal squamous cell carcinoma were reviewed regularly after surgery.

chemotherapy

Peng Lin, professor

Xing Ru Ping

Patients with thoracic esophageal squamous cell carcinoma after total two-field lymph node dissection were randomized into the adjuvant chemotherapy group or the postoperative observation group

Patients with T≥3 or N≥1 thoracic esophageal squamous cell carcinoma after total two-field lymph node dissection were randomly enrolled into the experimental group for adjuvant chemotherapy or the controlled group for postoperative observation. The experimental group received 4-course chemotherapy of docetaxel combined with nedaplatin, and to observe the 3-year progression free survival (DFS) and 5-year overall survival (OS) in two groups.

Study on Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma

A Prospective, Randomized Controlled Clinical Trial of Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma

Patients were images with computed tomography (CT) scan

Sun Yat-sen University

Clinical Professor

After esophagectomy, patients in Arm B will receive adjuvant chemotherapy, followed by elective nodal irradiation (ENI)

After esophagectomy, patients in Arm A will receive adjuvant chemotherapy only

Elective nodal irradiation (ENI)

Adjuvant chemotherapy only

Xu-Wei Cai, M.D., Ph.D.

Xiao-Long Fu, M.D., Ph.D.

Is elective nodal irradiation (ENI) necessary for patients with thoracic esophageal cancer after esophagectomy and with pathological stage of T1-2,N+,M0?

Patient Population:

Thoracic esophageal squamous cell carcinoma after esophagectomy with at least 15 lymph nodes removed for adequate nodal staging.

R0 resection; T1-2, N+, M0.

Scheme:

After esophagectomy, patients are firstly stratified by numbers of lymph node metastasis (\<3 or \>=3). Then patients are randomized to 2 arms:

Arm A:

Adjuvant chemotherapy (4 cycles).

Arm B:

Adjuvant chemotherapy (4 cycles) + Elective Nodal Irradiation (bilateral supraclavicular fossa and mediastinum).

Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0

Is Elective Nodal Irradiation (ENI) Necessary For Patients With Thoracic Esophageal Squamous Cell Carcinoma Who Undergo Esophagectomy And With Pathological Stage Of T1-2,N+,M0 -- A Randomized Phase Ⅲ Trial

To evaluate elective nodal irradiation (ENI) is better for the overall survival of patients with thoracic esophageal cancer after esophagectomy who with pathological stage of T1-2, N positive, M0

the incidence rate of adverse events, especially radiation-induced lung toxicity

To evaluate the rationality of ENI after esophagectomy by analyzing the therapeutic failure patterns especially by comparing the in-field and out-of-field recurrences

The First Affiliated Hospital of Soochow University

The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China

Jiangsu Cancer Institute & Hospital

Affiliated Hospital of Jiangsu University

Zhejiang Cancer Hospital

First Affiliated Hospital of Wenzhou Medical University

Zhejiang University

The First Affiliated Hospital of Anhui Medical University

Anhui Provincial Hospital

Fujian Cancer Hospital

Shanghai Chest Hospital

Shanghai Pulmonary Hospital, Shanghai, China

RenJi Hospital

Fudan University

Xiao-Long Fu / Professor

Fluorouracil

Cisplatin

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

After esophagectomy, patients in Arm A will receive Large field radiation (tumor bed + ENI (elective nodal irradiation)) + Sequential chemotherapy

After esophagectomy, patients in Arm B will receive small field radiation (tumor bed only) + Sequential chemotherapy

In Arm A, postsurgical radiation target volume includes tumor bed and elective nodes area

enlarge irradiation volume

In Arm B, postsurgical radiation target volume includes tumor bed only

Small volume radiation

cisplatin

fluorouracil

Xiao-Long Fu, M.D, Ph.D.

A randomized phase II trial to estimate the optimal radiation volume of postsurgical radiation for patients with locoregionally advanced thoracic esophageal squamous cell carcinoma (T3-4, any N, M0).

Patient Population:

Thoracic esophageal squamous cell carcinoma after esophagectomy with at least 15 lymph nodes removed for adequate nodal staging.

T3-4, any N, M0.

Scheme:

After esophagectomy, patients are firstly stratified by 2 factors: (1)number of lymph node metastasis (\<3 or \>=3) and (2)tumor resection status (R1 resection or R2 resection).

Note: Pathological R0 resection status is required for this study. So here R1 and R2 resection are not actually pathological status of resection, only clinical judgement by physician based on the chest-CT before esophagectomy.

Then patients are randomized to 2 arms:

Arm A:

Large field radiation (tumor bed + ENI (elective nodal irradiation)) + Sequential chemotherapy (4 cycles).

Arm B:

Small field radiation (tumor bed only) + Sequential chemotherapy (4 cycles).

A Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Esophageal Cancer

A Randomized Phase II Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Locoregionally Advanced Thoracic Esophageal Squamous Cell Carcinoma

To evaluate if the survival outcome of postsurgical radiation with a small target volume involved tumor bed only is not worse than a large volume (tumor bed and elective nodes) for patients with locoregionally advanced thoracic esophageal squamous cell carcinoma.

To evaluate the incidence rate of adverse events-especially radiation-induced lung toxicity

To evaluate the rationality of radiation target volumes by analyzing the therapeutic failure patterns especially by comparing the in-field and out-of-field recurrences.

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

The subjects were randomly divided into the group of camrelizumab combined with paclitaxel and cisplatin or the group of camrelizumab combined with albumin bound paclitaxel and cisplatin according to the ratio of 1:1. Esophageal cancer resection was performed after 3 cycles of medication (the researchers decided the follow-up treatment according to the postoperative pathological situation). At the end of the treatment, the patients were followed up for safety and effectiveness.

Camrelizumab: intravenous drip, fixed dose 200 mg, D1, repeated once every 3 weeks.

Albumin bound paclitaxel: 130 mg / m2, intravenous drip for 30 minutes, D1, D8, repeated every 3 weeks.

Cisplatin: 75 mg / m2, intravenous drip for 120 minutes, D1, repeated every 3 weeks.

Camrelizumab+Albumin bound paclitaxel+Cisplatin

Camrelizumab: intravenous drip, fixed dose 200 mg, D1, repeated once every 3 weeks.

Paclitaxel: 80 mg / m2, intravenous drip for 180 minutes, D1, D8, repeated every 3 weeks.

Cisplatin: 75 mg / m2, intravenous drip for 120 minutes, D1, repeated every 3 weeks.

Camrelizumab+ Paclitaxel+ Cisplatin

This is a randomized, open, two arm phase II clinical study. 40 patients are included in the exploratory study. The dominant population with higher biomarker positive / IO score was identified to provide the basis for the later phase III study. The subjects were randomly divided into the group of camrelizumab combined with paclitaxel and cisplatin or the group of camrelizumab combined with albumin bound paclitaxel and cisplatin according to the ratio of 1:1. The treatment cycle was every 3 weeks. The curative effect was evaluated when the treatment cycle was 2, and the resection of esophageal cancer was considered after 3 cycles. Postoperative adjuvant therapy was based on the patient's condition and surgical results; For patients with R0 resection, postoperative adjuvant treatment is not recommended. For patients with R1 / R2 resection, multi-disciplinary joint discussion and consultation are recommended to propose individualized comprehensive treatment.

The Neoadjuvant Treatment of Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

Camrelizumab Combined With Chemotherapy for Neoadjuvant Treatment of Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma：A Phase II Clinical Study to Explore the Relationship Between Biomarkers and Efficacy

t has a good value in predicting the efficacy of immunotherapy, and is helpful for the accurate formulation of treatment plan and the accurate evaluation of prognosis of patients with esophageal cancer.

Assess ORR, defined as Investigator-assessed CR + PR, per RECIST 1.1.

Percentage of patients with CR/PR/SD in the number of patients that whose tumour can be evaluated.

The DFS will be defined as the time of patients alive without local recurrence or distant metastasis of disease from the date of the administration of treatment.

OS is defined as the time from registration to death due to any cause, or censored at date last known alive. Measured by the method of Kaplan and Meier

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study on Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma	NCT04174079	Thoracic Esopha...	chemotherapy	18 Years - 75 Years	Sun Yat-sen University
Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0	NCT01398449	Esophageal Squa...	Elective nodal ... Adjuvant chemot...	18 Years - 70 Years	Fudan University
Study on Adjuvant Chemotherapy After Total Two-field Lymph Node Dissection of Thoracic Esophageal Squamous Cell Carcinoma	NCT04174079	Thoracic Esopha...	chemotherapy	18 Years - 75 Years	Sun Yat-sen University
A Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Esophageal Cancer	NCT01391572	Esophageal Squa...	enlarge irradia... Small volume ra... cisplatin fluorouracil	18 Years - 70 Years	Fudan University
A Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Esophageal Cancer	NCT01391572	Esophageal Squa...	enlarge irradia... Small volume ra... cisplatin fluorouracil	18 Years - 70 Years	Fudan University
A Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Esophageal Cancer	NCT01391572	Esophageal Squa...	enlarge irradia... Small volume ra... cisplatin fluorouracil	18 Years - 70 Years	Fudan University
Is ENI Necessary For Patients With Thoracic Esophageal Cancer After Esophagectomy And With Pathological Stage Of T1-2,N+,M0	NCT01398449	Esophageal Squa...	Elective nodal ... Adjuvant chemot...	18 Years - 70 Years	Fudan University
A Trial Estimating The Optimal Radiation Volume Of Postsurgical Radiation For Patients With Esophageal Cancer	NCT01391572	Esophageal Squa...	enlarge irradia... Small volume ra... cisplatin fluorouracil	18 Years - 70 Years	Fudan University
The Neoadjuvant Treatment of Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma	NCT04937673	Thoracic Esopha...	Camrelizumab+Al... Camrelizumab+ P...	18 Years - 75 Years	Peking University

Spots Global Cancer Trial Database for thoracic esophageal squamous cell carcinoma