Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Rare Diseases

Recurrence

Esophageal Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

The purpose of this study is to observe and evaluate the correlation between ctDNA-MRD and the therapeutic effect and prognosis of stage II-IVA operable esophageal squamous cell carcinoma.

ESCC patients with II-IVA resection will undergo MRD examination at the following time: the first examination is before the operation, the second examination is 7-10 days after the operation, and then 1 month after the operation, 2 weeks after the end of adjuvant treatment (if available), the follow-up period (every 3 months if there is no postoperative treatment) and the progress (the progress of the disease confirmed by the researcher), the patients will receive close MRD monitoring to evaluate the correlation between ctDNA-MRD and therapeutic efficacy and prognosis.

Peripheral blood before and after surgery, 2 weeks after the end of adjuvant treatment, follow-up period (every 3 months if there is no postoperative treatment), the progress of the disease, as well as the pathological tissues of the initial diagnosis puncture or surgical resection

An Exploratory Study of ctDNA-MRD in Predicting the Efficacy of Esophageal Squamous Cell Carcinoma

Application of ctDNA-MRD in the Prediction of Curative Effect, Recurrence Monitoring and Prognosis Evaluation of Esophageal Squamous Cell Carcinoma (ESCC) During Perioperative Treatment

Evaluation of progression-free survival rate of esophageal squamous cell carcinoma patients with different MRD status during perioperative period

Guangzhou Institute of Respiratory Disease

GuangzhouIRD

Anti-Infective Agents

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Platelet Aggregation Inhibitors

All Drugs and Chemicals

Herbal and Botanical

Andrographolide

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Antiprotozoal Agents

Antiparasitic Agents

Antiviral Agents

Andrographis

Chirata

Single lot of Andrographis paniculata (AP) concentrated granules (Andrographis Herba) will be manufactured by Nong's Company Limited under GMP standard

Andrographis Paniculata

Philip WY Chiu, MD

This is a prospective cohort study on the effect of Andrographis Paniculata (AP) on palliative management of patients with advanced or metastatic esophageal cancer. A total of 30 patients with locally advanced or metastatic squamous esophageal cancer will be recruited for the trial.

The Effect of Andrographis Paniculata (AP) on Palliative Management of Advanced Esophageal Cancer

Symptomatic relief of Dysphagia and quality of life after treatment Dysphagia measured by Dysphagia score Quality of Life measured by EORTC-QLQ-C30

Difficulty to swallow by dysphagia grade 0 = able to eat normal diet / no dysphagia.

1. = able to swallow some solid foods
2. = able to swallow only semi solid foods
3. = able to swallow liquids only
4. = unable to swallow anything / total dysphagia

Side effects related to AP including

1. Gastrointestinal upset
2. Nausea and Vomiting
3. Allergy
4. Diarrhoea
5. Abdominal pain
6. Dizziness

Chinese University of Hong Kong

Professor

Antineoplastic Agents

Paclitaxel

Fluorouracil

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle

nanoparticle albumin-bound paclitaxel

Qiong Zhao, MD

Albumin-bound paclitaxel regimen in advanced NSCLC has a better tumor response rate and safety than solvent-based paclitaxel. However, the safety and efficacy is uncertain in neoadjuvant therapy in esophageal cancer. The objective of this single-arm phase II trial was to evaluate the benefit of neoadjuvant chemotherapy with nanoparticle albumin-bound paclitaxel plus 5-fluorouracil in patients with locally advanced esophageal squamous cell carcinoma.

In the past decade, clinical trials have evaluated the role of neoadjuvant chemotherapy, radiation, or both, for patients with surgically resectable esophageal carcinoma, but have all failed to demonstrate a consistent survival benefit. In Eastern countries, preoperative chemotherapy followed by radical surgery became one of the treatment strategies for resectable, clinical stage II or III esophageal cancer. In an effort to improve the efficacy of systemic chemotherapy, we conducted a prospective study to evaluate the regimen of nanoparticle albumin-bound paclitaxel plus 5-fluorouracil as perioperative therapy for patients with resectable esophageal carcinoma.

Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Squamous Cell Carcinoma of Esophagus

A Phase II Trial of Neoadjuvant Chemotherapy With Nanoparticle Albumin-bound Paclitaxel and Fluorouracil Followed by Surgery in Patients With Locally Advanced Squamous Cell Carcinoma of Esophagus

pathological response rate and clinical response rate

Adverse events were classified according to U.S. National Cancer Institute common toxicity criteria, version 4.0

Zhejiang University

Chief of Department of Thoracic Oncology

Amino Acids

Afatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

International Nonproprietary Name (INN): BIBW 2992 Pharmacological dosage form: Film-coated tablet Supplier: Boehringer Ingelheim Pharma GmbH \& Co. KG Unit content: 40 mg, 30 mg, 20 mg film-coated tablet (BIBW 2992 content in film-coated tablet is related with equivalent free base BIBW 2992.) Daily dose: 40 mg Dosing period: To be successively administered once daily until a disease will develop, an unacceptable adverse event will occur, or another reason requiring discontinuation of the study will occur; For administration, study treatment consists of periods(each 4 weeks(28 days)).

Route of administration: Orally (Take by swallowing) Dosage: Once daily

BIBW2992

As a 2nd generation EGFR-TKI that irreversibly binds to EGFR receptors, afatinib showed the possibility of superior effects to 1st generation TKIs such as erlotinib and gefitinib. In a phase III study LUX-lung 3 in patients with EGFR mutation-positive non-small-cell lung cancer, afatinib monotherapy showed longer progression-free disease survival time of 11.1 months than that (6.9 months) of pemetrexed/cisplatin combination therapy. Based on such the results, it is currently recommended as the standard first-line treatment for EGFR mutation-positive lung cancer, and clinical studies are also being actively conducted in other types of carcinomas characterized by EGFR gene mutation and overexpression. Thirty (30) solid cancer patients were included in a phase I trial of afatinib, and of them, a patient with esophageal cancer had partial response. Taken together, based upon the results from clinical trials of afatinib conducted so far, 7 out of 15 esophageal cancer patients achieved clinical responses of 3 months or longer.

Hence, the overall results from previous studies of gefitinib and erlotinib as EGFR TKIs and our study of dacomitinib, as well as from preceding studies of afatinib - a 2nd generation EGFR TKI - suggest the possibility of an effective therapy in esophageal cancer characterized by well-known EGFR overexpression. In this phase II trial, afatinib shall be administered to patients with squamous cell carcinoma of esophagus to evaluate its effects and toxicity. Also, biomarkers to predict responses to afatinib shall be explored through further studies.

A Phase II Trial of Afatinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of Esophagus

Yonsei University

Disease Progression

Docetaxel

Oxaliplatin

Cisplatin

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Chemotherapy plus best supportive care with follow up at each cycle of the treatment with FU-CDDP; LV5FU2-CDDP; FOLFOX; TPF

Best supportive care with follow up every 6 weeks

every 21 days:

* Fluoro-uracil \[800 mg/m2, day 1 to day 5\]
* CisPlatin \[75 mg/m2, day 1 or day 2\]

FU-CDDP

every 14 days:

* Elvorin \[200 mg/m2, 2h IV, day 1 and day 2\]
* Fluoro-uracil \[400 mg/m2 as a bolus, day 1 and day 2\]
* Fluoro-uracil \[600 mg/m2, 22h continous infusion, day 1 and day 2\]
* CisPlatin \[50 mg/m2, day 2\]

LV5FU2-CDDP

every 14 days:

* Oxaliplatin \[85 mg/m2 by 2h infusion, day 1\]
* Fluoro-uracil \[400 mg/m2 as a bolus, day 1 and day 2\]
* Fluoro-uracil \[600 mg/m2, by 22h continous infusion, day 1 and day 2\]
* Elvorin \[500 mg/m2, day 1 and day 2\]

FOLFOX

every 21 days:

* Docetaxel \[30 mg/m2, day 1 and day 8\]
* CisPlatin \[60 mg/m2, day 1\]
* Fluoro-uracil \[200 mg/m2/day by continous infusion\]

Or every 21 days:

* Docetaxel \[50 mg/m2, day 1\]
* CisPlatine \[70 mg/m2, day 1\]
* Fluoro-uracile \[700 mg/m2 /day, day 1 to day 5\]

See European professionnal recommendations (ESMO 2009) Exemples : antalgic treatment, nutritional support, ...

Best Supportive Care

Antoine ADENIS, MD, PhD

Interest of continuing systemic chemotherapy or not , after a short initial treatment (6 weeks) in patients who are in response or stable disease("Discontinuation design ")of patients with metastatic oesophageal cancer of squamous cell type

The secondary aims would be to study : toxicity, the overall survival rate, a study of costs and quality of life.

As the data in litterature does not provide the basis for well-argued statistical hypothesis, it is suggested to randomize 30 patients per arm. An IDMC will come to a decision after the inclusion of 10, 20 ans 40 patients on the efficacy and the toxicity profile and on whether to maintain the current clinical position, justifying randomisation . In order to take into account any possible effects of prior concomitant radiochemotherapy, patient will be stratified according to whether they have already undergone chemotherapy or radiochemotherapy.

Benefit of Chemotherapy Over Best Supportive Care in Metastatic and Squamous Cell-type Esophageal Cancer.

A Multicenter Randomized Phase II Study to Evaluate the Benefit of Chemotherapy Plus Best Supportive Care (BSC) Versus BSC in Patients With Metastatic Oesophageal Cancer of Squamous Cell-type Who Have Not Experienced a Disease Progression or Unacceptable Toxicity After a 6-weeks Chemotherapy Course .

According to the NCI-CTCAE V4.0 grading scale

EOTRC QLQ-C30 questionnaire and the oesophagus QLQ-OES18 module

EQ-5D questionnaire

Data collected :

* Hospitalization
* day hospital visit
* Chemotherapy drugs administered
* Home medical care
* Radiotherapy
* Oncologist visits, General Practitioner Visits
* Laboratory and radiologic tests

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Exploratory Study of ctDNA-MRD in Predicting the Efficacy of Esophageal Squamous Cell Carcinoma	NCT05759325	Squamous Cell C...		18 Years - 80 Years	Guangzhou Institute of Respiratory Disease
The Effect of Andrographis Paniculata (AP) on Palliative Management of Advanced Esophageal Cancer	NCT04196075	Squamous Cell C...	Andrographis Pa...	18 Years -	Chinese University of Hong Kong
Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Squamous Cell Carcinoma of Esophagus	NCT02033538	Squamous Cell C...	nanoparticle al...	18 Years - 75 Years	Zhejiang University
A Phase II Trial of Afatinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of Esophagus	NCT02353936	Squamous Cell C...	BIBW2992	20 Years -	Yonsei University
Benefit of Chemotherapy Over Best Supportive Care in Metastatic and Squamous Cell-type Esophageal Cancer.	NCT01248299	Squamous Cell C...	FU-CDDP LV5FU2-CDDP FOLFOX TPF Best Supportive...	18 Years -	Centre Oscar Lambret
An Exploratory Study of ctDNA-MRD in Predicting the Efficacy of Esophageal Squamous Cell Carcinoma	NCT05759325	Squamous Cell C...		18 Years - 80 Years	Guangzhou Institute of Respiratory Disease
A Phase II Trial of Afatinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of Esophagus	NCT02353936	Squamous Cell C...	BIBW2992	20 Years -	Yonsei University

Spots Global Cancer Trial Database for squamous cell carcinoma of esophagus