Neoplasms

All Conditions

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Paclitaxel

Albumin-Bound Paclitaxel

Erlotinib Hydrochloride

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV ，dosing schedule: 45mg/m2/w.

The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV (45mg/m2/w) and erlotinib PO QD.

Erlotinib

Radiation therapy

Xu jianming, M.D.

Zhao chuanhua

The purpose of this study is to test the safety and effectiveness of erlotinib and chemoradiotherapy in patients with unresectable esophageal or gastro-esophageal squamous cancer .

Paclitaxel Plus Radiation With Erlotinib to Treat Esophageal Squamous Carcinoma

A Randomized Phase III Study: Paclitaxel Plus Radiation Therapy With or Without Erlotinib in Treating Patients With Esophageal Squamous Carcinoma

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Recurrence

Esophageal Neoplasms

Disease Attributes

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Treatment with Poziotinib

Hye Ryun Kim, MD

Esophageal cancer is the sixth most common cause of cancer deaths worldwide. Esophageal adenocarcinoma has become more common in Western countries. In many Asian countries, however, Esophageal Squamous Cell Carcinoma (ESCC) represents the most common esophageal cancer. In palliative chemotherapy for metastatic or recurrent ESCC, A combination of 5-fluorouracil and platinum was prescribed as a standard treatment for about 20 years. With this traditional regimen, the median progression free survival is approximately 7 months, and 1-year survival rate is reported to be 34%. Combinations of taxane and anthracycline are also considerable, but also shows the median survival less than one year. Though cytotoxic chemotherapy is current main treatment option, molecularly targeted agents are recently incorporated to improve survival in ESCC. There is a strong rationale for investigation of biologic agents targeting Epithelial Growth Factor Receptor (EGFR) family in ESCC. EGFR is frequently overexpressed in esophageal cancer and is known to be associated with poor prognosis. Several EGFR tyrosine kinase inhibitors (TKIs) have been studied in esophageal cancer subjects and have shown clinical effects. In a recent Phase II trial using dacomitinib, pan-human epidermal growth receptor TKI, Partial response was observed in 10 of the 49 esophageal cancer subjects, with a response rate of 20.8%.

Based on notable rationale in exploring impact of EGFR inhibition, we suggest multicenter phase II study to determine antitumor activity and safety of a other potent pan-HER inhibitor, Poziotinib in Esophageal Squamous cell carcinoma.

A Trial to Evaluate the Efficacy of Poziotinib, Pan HER Inhibitor in Recurrent/Metastatic Esophageal Cancer (R/M ESCC)

A Single Arm Phase II Trial to Evaluate the Efficacy of Poziotinib, Pan HER Inhibitor in Recurrent/Metastatic Esophageal Cancer (R/M ESCC)

To evaluate the safety of Poziotinib, pan HER inhibitor in recurrent/metastatic esophageal cancer

Yonsei University

Esophageal Squamous Cell Carcinoma

The goal of observational study is to learn about the outcomes of the participants. The main questions it aims to answer are:

1. ESD additional postoperative radiotherapy in patients with non healing SESCC overall survival (OS) and disease-free survival (DFS)
2. The adverse events (AE) of additional radiotherapy after ESD for non-curative SESCC patients were counted, and its safety was evaluated.

Participants will receive radiation therapy as necessary.

This study is an in ESD subjects, early postoperative esophageal cancer pathology returns have cut edge positive, lymphatic vascular invasion, SM2 - SM3 or pathologic stage under the condition of low degree of differentiation, observe additional radiation noninferiority and safety of single arm, multicenter, phase II clinical study.

The test plan into the group of 40 cases of the subjects, the ESD additional postoperative radiotherapy group, using three dimensional conformal radiation therapy and intensity-modulated radiation therapy technology. Good ESD within 2 months, after the ulcer healing began RT as a supplementary treatment. All patients underwent CT simulation before treatment, and the location of the tumor bed was determined according to the lesion location under ultrasound gastroscopy before ESD and the scar tissue formed after ESD. If necessary, titanium clips were placed under gastroscopy before the first radiotherapy to locate the tumor bed, that is, GTVtb. CTV1 of cervical and middle and upper thoracic esophageal cancer included bilateral supraclavicular and mediastinal lymph nodes to the tracheal bifurcation area, the so-called "short T" field. CTV1 of lower thoracic esophageal cancer includes mediastinum, perigastric and lymphatic drainage areas above the celiac trunk. Plans to target (PTV) has CTV1 outside enlarge margins of 0.5 cm. The dose to PTV was 45Gy/25 fractions /5 weeks (5 days/week), and the dose to PGTVtb was 50Gy/25F(simultaneous boost). For patients with positive margins, the PTV dose was 48Gy/30 fractions /6 weeks (5 days/week), and the PGTVtb dose was 60Gy/30 fractions. The study was followed up for a total of 3 years. During the study period, the subjects were evaluated by tumor imaging before and after the additional radiotherapy. All participants were treated until disease progression, development of unacceptable toxicity, receipt of new antineoplastic therapy, withdrawal of informed consent, loss to follow-up, or death, or other conditions judged by the investigator to warrant discontinuation of treatment.

A Clinical Study of Non-curative Resection Plus Radiotherapy After Endoscopic ESD for Superficial Esophageal Squamous Cell Carcinoma

A Single-arm, Prospective, Multi-center Phase II Clinical Study of Non-curative Resection Plus Radiotherapy After Endoscopic ESD for Superficial Esophageal Squamous Cell Carcinoma

OS is defined as the interval from the date of enrollment to the death of the subject from any cause.

DFS is defined as the interval from the date of enrollment to first disease progression, whichever occurred first.

Xiaomeng Zheng

Master Degree Candidate

Afatinib

JMT101 combined with two dose levels of afatinib will be tested according to the "3 + 3" dose-escalation design. The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days).

Once the safe and effective dose has been determined, an expansion cohort will be recruited to further evaluate the efficacy and safety of the selected dose.

JMT101 will be administered intravenously at 6 mg/kg every 2 weeks (q2w) in each 28-week cycle.

JMT101

Afatinib will be administered orally at 30 mg or 40 mg per day (qd) in each 28-week cycle.

Lin Shen

Yongsheng Li

Dong Qian

Suxia Luo

Chunqing Li

This study is a multi-center, open-label, phase Ib study to evaluate the safety, tolerability and efficacy of JMT101 combined with afatinib in patients with advanced esophageal squamous cell carcinoma who have failed standard treatment.

This is a multicenter, open-label, dose-escalated phase Ib study aimed to evaluate the safety, tolerability, and efficacy of JMT101 combined with afatinib in patients with advanced esophageal squamous cell carcinoma who have failed standard treatment. This study consists of two stages: dose-escalation stage and dose expansion stage. The dose-escalation stage will be conducted to determine the maximum tolerated dose (MTD) of JMT101 combined with afatinib in patients with advanced esophageal squamous cell carcinoma based on a 3+3 design. JMT101 will be given by intravenous infusion at 6 mg/kg (q2w) of each 28-week cycle. Afatinib will be sequentially administered at 30 mg and 40 mg (qd) of each 28-week cycle. One dose cohort which is verified to be well-tolerated and safe in dose-escalation stage will be selected for dose-expansion to further explore the safety, pharmacokinetic and efficacy of the study drug.

JMT101 Combined With Afatinib in Patients With Advanced Esophageal Squamous Cell Carcinoma After Standard Therapy

A Multicenter, Open-label, Phase Ib Study to Evaluate the Safety and Efficacy of JMT101 Combined With Afatinib in Patients With Advanced Esophageal Squamous Cell Carcinoma Who Have Failed Standard Therapy

The biomarkers include PIK3CA, PTEN, KRAS, BRAF, CDH1, EGFR status detected by immunohistochemical (IHC) and fluorescence in-situ hybridization (FISH).

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).

Measure of time from first response to disease progression or death

Percentage of patients who achieve partial response (PR) or complete response (CR) or stable disease (SD) based on Response Evaluation Criteria In Solid Tumors (RECIST)

Measure of time from study treatment to disease progression or death

Measure of time from study treatment to patient's death or lost to follow-up

area under the plasma concentration versus time curve

anti-drug antibody which can result in treatment failure by blocking the pharmacological function of the drug.

neutralizing anti-drug antibody which can result in treatment failure by blocking the pharmacological function of the drug.

Peking University

Clinical Professor

Cisplatin

Disitamab vedotin

Nedaplatin

Immunoconjugates

Immunologic Factors

Dose 1: RC48 2.5mg/kg intravenous infusion, d1 once every 3 weeks;

Camrelizumab dose: 200mg, intravenous infusion 30-60min, d1 once every 3 weeks;

Platinum (cisplatin or nedaplatin) : Cisplatin 75mg/m2, added into 500ml 0.9% sodium chloride injection for infusion, hydration and alkalization of -1d, d1, d2, once every 3 weeks; Nedaplatin 75mg/m2 was added to 500ml 0.9% sodium chloride injection, once every 3 weeks.

Dose 2: rc48 2.0mg/kg, d1, once every 3 weeks; Camrelizumab 200mg, d1 once every 3 weeks; Platinum: Cisplatin 75mg/m2(or nedaplatin 75mg/m2), d1, once every 3 weeks

Phase I: Three subjects with HER2 overexpression (IHC 2+/3+) were initially enrolled. If dose-limiting toxicity (DLT) was observed in two of the three subjects, the study was continued from dose 1 to dose 2. If ≤1 DLT is observed in 3 subjects, continue to enroll 3 patients, and if ≤2 DLT is observed in 6 subjects, proceed to the second phase. If \> 2 cases of DLT are observed in 6 subjects, adjust to dose 2 for phase 2.

Dose 1: RC48 2.5mg/kg, d1, once every 3 weeks; Camrelizumab 200mg, d1 once every 3 weeks; Platinum: Cisplatin 75mg/m2(or nedaplatin 75mg/m2), d1, once every 3 weeks

Dose 2: RC48 2.0mg/kg, d1, once every 3 weeks; Camrelizumab 200mg, d1 once every 3 weeks; Platinum: Cisplatin 75mg/m2(or nedaplatin 75mg/m2), d1, once every 3 weeks

The second stage: sample size expansion stage. RP2D obtained at stage 1 continues to be enrolled in up to 20 patients until disease progression or intolerable toxicity occurs.

RC48+PD-1+platinum-based

Xianbao Zhan, Doctor

This is a single-arm, exploratory clinical study.

This is a single-arm, exploratory clinical study. Aim to explore the safety and efficacy of Vedicetuzumab combined with an immune checkpoint inhibitor (carrellizumab) and platinum-based first-line treatment for locally advanced/metastatic HER2 overexpression (IHC 2+/3+) esophageal squamous cell carcinoma.

DV Combined With PD-1 and Platinum-based First-line Treatment in Patients With HER2 IHC2+/3+ ESCC

DV Combined With PD-1 and Platinum-based First-line Treatment in Patients With Locally Advanced or Metastatic HER2 IHC2+/3+ Esophageal Squamous Cell Carcinoma

Defined as maximum tolerated dose or maximum administration dose.

The time between the start of treatment and the onset of disease progression or death

The percentage of patients whose tumors have shrunk to a certain amount and remain there for a certain amount of time, including complete response (CR) and partial response (PR) cases

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Paclitaxel Plus Radiation With Erlotinib to Treat Esophageal Squamous Carcinoma	NCT01752205	Esophageal Squa...	Paclitaxel Erlotinib Radiation thera...	18 Years -	The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
A Trial to Evaluate the Efficacy of Poziotinib, Pan HER Inhibitor in Recurrent/Metastatic Esophageal Cancer (R/M ESCC)	NCT03770988	Inoperable or R...	Treatment with ...	20 Years -	Yonsei University
A Clinical Study of Non-curative Resection Plus Radiotherapy After Endoscopic ESD for Superficial Esophageal Squamous Cell Carcinoma	NCT06160557	Esophagus Cance... Radiotherapy Endoscopic Muco...		18 Years - 75 Years	Fujian Medical University
JMT101 Combined With Afatinib in Patients With Advanced Esophageal Squamous Cell Carcinoma After Standard Therapy	NCT05164848	Esophageal Squa...	JMT101 Afatinib	18 Years -	Peking University
DV Combined With PD-1 and Platinum-based First-line Treatment in Patients With HER2 IHC2+/3+ ESCC	NCT06055153	Esophageal Squa... HER-2 Protein O...	RC48+PD-1+plati...	18 Years -	Changhai Hospital

Spots Global Cancer Trial Database for esophageal squamous carcinoma