Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，SHR-1210 200mg，Day 2，every 3 weeks, maximum 6 cycles, then SHR-1210 maintenance

Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，placebo，Day 2，every 3 weeks, maximum 6 cycles, then placebo maintenance

SHR-1210

Placebo

paclitaxel

cisplatin

Ruihua Xu

Qing Yang

This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of SHR-1210 + paclitaxel + cisplatin vs placebo+paclitaxel +cisplatin as 1L therapy for advanced esophageal cancer patients in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.

In this study, eligible subjects will be randomized into study arm or control arm. Treatment cycles of chemotherapy will be at most 6 cycles which would be decided by the investigators. Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) and overall survival (OS) will be the primary outcomes.

Study of SHR-1210 in Combination With Chemotherapy in Advanced Esophageal Cancer

PD-1 Antibody SHR-1210 Combined With Paclitaxel and Cisplatin Versus Placebo Combined With Paclitaxel and Cisplatin as First-line Therapy for Advanced Esophageal Cancer: a Randomized, Double-blinded, Controlled, Multi-center Phase III Trial

To evaluate the incidence of ADAs against SHR-1210

based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)

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.

Jiangsu HengRui Medicine Co., Ltd.

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Disease Progression

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Hematinics

Tislelizumab

Immunomodulating Agents

Liver Extracts

Antineoplastic Agents, Immunological

Intensity-modulated radiotherapy (IMRT):

Esophageal primary tumor: 39.6Gy/2.2Gy Bone metastasis: 30Gy/3Gy Lung, liver, brain metastases, metastatic lymph nodes: 45Gy/3Gy

During concurrent radiation therapy:

Drug: Tislelizumab 200 mg IV Q3W Drug: Nab Paclitaxel 75 mg/m² IV QW Drug: Cisplatin 25 mg/m² IV QW

During consolidation therapy:

Drug: Tislelizumab 200 mg IV Q3W Drug: Nab Paclitaxel 220 mg/m² IV Q3W Drug: Cisplatin 75 mg/m² IV Q3W

Drug: Tislelizumab 200 mg IV Q3W Drug: Nab Paclitaxel 220 mg/m² IV Q3W Drug: Cisplatin 75 mg/m² IV Q3W

Esophageal primary tumor: 39.6Gy/2.2Gy Bone metastasis: 30Gy/3Gy Lung, liver, brain metastases, metastatic lymph nodes: 45Gy/3Gy

Intensity-modulated radiotherapy (IMRT)

During concurrent radiation therapy: 25 mg/m² IV QW During consolidation therapy: 75 mg/m² IV Q3W

During concurrent radiation therapy: 75 mg/m² IV QW During consolidation therapy: 220 mg/m² IV Q3W

Nab paclitaxel

Yongshun Chen, MD

Liwei Chen

This study is a multicentre, randomised, parallel-controlled, open-label, 3 phase clinical trial. The subjects were untreated, unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma with low PD-L1 expression. Patients were randomly assigned to receive chemoradiation or chemotherapy in combination with Tislelizumab at a ratio of 1: 1. The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. We hypothesized that in advanced esophageal squamous cell carcinoma patients with low PD-L1 expression, chemoradiation versus chemotherapy in combination with Tislelizumab will significantly improve PFS.

A Study of Chemoradiation in Combination With Tislelizumab as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

Chemoradiation Versus Chemotherapy in Combination With Tislelizumab as First Line Treatment for Advanced Esophageal Squamous Cell Carcinoma With Low PD-L1 Expression (RENMIN-236): Multicentre, Randomised, Phase 3 Trial

PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first

Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the subject was known to be alive.

Objective response rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation as determined by BICR, recorded between the date of randomization and the date of objectively documented progression (per RECIST 1.1) or the date of subsequent anti-cancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions. Complete response is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to \<10 mm.

DOR is defined as the time from the first determination of an objective response until the first documentation of progression assessed by the investigator per RECIST v1.1 or death, whichever comes first

AEs are documented according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4

Renmin Hospital of Wuhan University

Professor

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Adenocarcinoma

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Micronutrients

Bone Density Conservation Agents

Vitamins

Irinotecan

Pembrolizumab

Leucovorin

Fluorouracil

Levoleucovorin

Oxaliplatin

Calcium

Folic Acid

Calcium, Dietary

Futibatinib

Immune Checkpoint Inhibitors

Hormones

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

Patients with Esophageal cancer (Adenocarcinoma or Squamous cell cancer) will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus investigator choice of SoC chemotherapy (FP or mFOLFOX6) for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase).

Patients with PDAC will receive Futibatinib administered once daily on a continuous dosing regimen in combination with pembrolizumab plus mFOLFIRINOX for 6 cycles (induction phase) following by Futibatinib combination with pembrolizumab (consolidation phase) .

400 mg once every 6-week-cycle, via IV infusion.

80 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy

4000 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 400 mg/m\^2 Q2W via bolus IV infusion followed by 2400 mg/m\^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.

2400 mg/m\^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.

2400 mg/m\^2 Q2W via continuous IV infusion, as part of mFOLFIRINOX chemotherapy.

5-FU

85 mg/m\^2 Q2W via IV infusion, as part of mFOLFIRINOX or mFOLFOX6 chemotherapy. 2400 mg/m\^2 Q2W via continuous IV infusion, as part of mFOLFIRINOX chemotherapy.

400 mg/m\^2 Q2W as part of mFOLFIRINOX or mFOLFOX6 chemotherapy.

200 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.

150 mg/m\^2 Q2W as part of mFOLFIRINOX chemotherapy.

Taiho Oncology, Inc

Rosen Lee

Allen Cohn

Mike Cusnir

Rutika Mehta

Gazala Khan

Carl Minniti

Sarbajit Mukherjee

Jennifer Chuy

Nashat Gabrail

Joseph Potz

Michael Gibson

David Wang

Jasmine Huynh

Mark Kochenderfer

Bruce Lin

Kurt Oettel

Anne Plaquinn

David Tougeron

Thorsten Goetze

Markus Moehler

Marc Diez Garcia

Carlos Jesus Gomez Martin

This is a nonrandomized, uncontrolled, open-label, multicenter Phase 2 study to evaluate the efficacy, safety, and tolerability of futibatinib in combination with PD-1 antibody-based SoC therapy in adult patients with solid tumors.

Patients with locally advanced, unresectable or metastatic esophageal cancer (EC) or pancreatic ductal adenocarcinoma (PDAC) will receive futibatinib in combination with pembrolizumab plus standard of care (SOC) chemotherapy. Patients with EC will receive Investigator choice of chemotherapy (FP or mFOLFOX6), patients with PDAC will receive mFOLFIRINOX. Subjects will receive futibatinib in combination with pembrolizumab plus standard of care (SOC) chemotherapy during induction phase of the study and will continue on futibatinib in combination with pembrolizumab in consolidation phase.

Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors

A Phase 2 Study of Futibatinib in Combination With PD-1 Antibody-based Standard of Care Therapy in Patients With Solid Tumors.

Defined as the proportion of patients experiencing a best overall response of partial response (PR) or complete response (CR) (per RECIST 1.1), based on investigator assessment

Safety will be assessed based on reported AEs (including SAEs), graded by CTCAE V5.0., and dose modifications.

defined as time from the first documentation of response to the first documentation of objective tumor progression or death due to any cause, whichever occurs first

defined as percentage of patients who achieve complete response, partial response or stable disease per RECIST 1.1 by investigator assessment

defined as the time from date of enrollment to the date of disease progression based on Investigator assessment of radiographic images or death, whichever occurs first

defined as percentage of patients without disease progression within 6 months of enrollment

Taiho Oncology, Inc.

HR070803 monotherapy will be administered by intravenous infusion

HR070803

Xiaoshuo Zhang

Kuaile Zhao

To evaluate the efficacy, safety and pharmacokinetic characteristics of HR070803 in the treatment of advanced esophageal cancer.

A Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer

An Open, Single-arm, Multicenter Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer

The study is designed to evaluate the objective response rate of HR070803 in patients with advanced esophageal cancer. ORR is defined as percentage of patients achieving a best response of complete response (CR) or partial response (PR) as per RECIST version 1.1.

The study is designed to evaluate the progression free survival of HR070803 in patients with advanced esophageal cancer. PFS is defined as the time from first medication to disease progression or death, whichever is earlier

The study is designed to evaluate the disease control rate of HR070803 in patients with advanced esophageal cancer. DCR is defined as the percentage of patients with a best response of CR, PR, or stable disease (SD)

The study is designed to evaluate the duration of response of HR070803 in patients with advanced esophageal cancer. DoR is defined as the time from first documentation of response (CR or PR whichever occurred first, as per RECIST version 1.1) to disease progression or death, whichever is earlier.

The study is designed to evaluate the overall survival of HR070803 in patients with advanced esophageal cancer. OS is defined as the time from first medication to death of any cause, censored for patients alive at data cut-off.

Safety and tolerability will consist of monitoring and recording all AEs and SAEs as characterized by type, incidence, severity, and the relationship to the study therapy. AEs will be evaluated for all treated patients using NCI-CTCAE V5.0.

Anti-MUC1 CAR-T cells will be prepared ex vivo using the T cells from the patients and infused back to the patients.

Anti-MUC1 CAR-T cells and PD-1 knockout Engineered T cells will be prepared ex vivo using the T cells from the patients and infused back to the patients.

PD-1 knockout Engineered T cells will be prepared ex vivo using the T cells from the patients and infused back to the patients.

Using the T cells from the patients' blood to produce anti-MUC1 CAR-T Cells and then the cells will be infused back to the patients.

Anti-MUC1 CAR-T cells

Using the T cells from the blood of the patients to prepare PD-1 knockout T cells, then the cells will be infused back to the patients.

PD-1 knockout Engineered T cells

Using the T cells from the blood of the patients to prepare anti-MUC1 CAR-T Cells and PD-1 knockout T cells, then the cells will be infused back to the patients

CAR-T combined with PD-1 Knockout T cells

Size Chen, MD, PhD

Zhizhou Huang, MSc

Guobiao Huang

Size Chen, MD,PhD

Yiguang Lin, MD, PhD

Micheal Yin, PhD

The study is to assess the safety and efficacy of the immunotherapies using anti-MUC1 CAR T cells and /or PD-1 knockout engineered T cells in the treatment of patients with advanced esophageal cancer.

This is a combined phase 1 and 2 clinical study. The aim of the study is to assess the safety and efficacy of the immunotherapies using anti- MUC1 CAR T cells alone, anti- MUC1 CAR T combining PD-1 knockout engineered T cells, and PD-1 knockout engineered T cell only in the treatment of patients with advanced esophageal cancer. The treatment outcomes from each group will be compared.

CAR T and PD-1 Knockout Engineered T Cells for Esophageal Cancer

Combination Therapy of Anti-MUC1 CAR T Cells and PD-1 Knockout Engineered T Cells for Advanced Esophageal Cancer

Safety and tolerability of dose of CART-cells and PD-1 Knockout T cells will be assessed using CTCAE v4.0.

Will be assessed according to the revised RECIST guideline v1.1

Measure the time from enrollment to death

Time from enrollment to date of first documented progression or date of death.

Guangzhou Anjie Biomedical Technology Co., Ltd.

The First Affiliated Hospital of Guangdong Pharmaceutical University

Associate Professor

Carboplatin

All enrolled patients undergo biomarker study and treatment study.

* Biomarker study: the baseline tumor tissue will be collected and analyzed via NGS and mIHC
* Treatment study: SHR-1210 plus albumin-bound paclitaxel and platinum-based chemotherapy

SHR-1210 (camrelizumab) + albumin-bound paclitaxel + Carboplatin

Combination therapy

Hongying Liao, Professor

Yuzhen Zheng, Doctor

This study intends to explore the predictive biomarkers by Next-generation sequencing (NGS) and multiple immunohistochemistry (mIHC) for the treatment of SHR-1210 in combination with paclitaxel and platinum in advanced esophageal cancer.

Study on the Biomarker of First-line Immunotherapy Combined With Chemotherapy in Advanced Esophageal Cancer

ORR is determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.

It is defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.

Defined as the time from the enrollment to death from any cause

The proportion of patients who have achieved complete response， partial response and Stable disease assessed by investigators according to Recist v 1.1.

All adverse event/Serious adverse event that occurred during the study period according to CTCAE v 4.03

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of SHR-1210 in Combination With Chemotherapy in Advanced Esophageal Cancer	NCT03691090	Advanced Esopha...	SHR-1210 Placebo paclitaxel cisplatin	18 Years - 75 Years	Jiangsu HengRui Medicine Co., Ltd.
A Study of Chemoradiation in Combination With Tislelizumab as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma	NCT05919030	Esophageal Squa...	Intensity-modul... Tislelizumab Cisplatin Nab paclitaxel	18 Years -	Renmin Hospital of Wuhan University
Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors	NCT05945823	Locally Advance... Esophageal Aden... Esophageal Squa... Siewert Type 1 ... Pancreatic Canc...	Futibatinib Pembrolizumab Cisplatin 5-FU Oxaliplatin Leucovorin Levoleucovorin Irinotecan	18 Years -	Taiho Oncology, Inc.
A Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer	NCT05425472	Advanced Esopha...	HR070803	18 Years - 75 Years	Jiangsu HengRui Medicine Co., Ltd.
CAR T and PD-1 Knockout Engineered T Cells for Esophageal Cancer	NCT03706326	Advanced Esopha...	Anti-MUC1 CAR-T... PD-1 knockout E... CAR-T combined ...	18 Years - 80 Years	The First Affiliated Hospital of Guangdong Pharmaceutical University
Study of SHR-1210 in Combination With Chemotherapy in Advanced Esophageal Cancer	NCT03691090	Advanced Esopha...	SHR-1210 Placebo paclitaxel cisplatin	18 Years - 75 Years	Jiangsu HengRui Medicine Co., Ltd.
A Study of Chemoradiation in Combination With Tislelizumab as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma	NCT05919030	Esophageal Squa...	Intensity-modul... Tislelizumab Cisplatin Nab paclitaxel	18 Years -	Renmin Hospital of Wuhan University
Study on the Biomarker of First-line Immunotherapy Combined With Chemotherapy in Advanced Esophageal Cancer	NCT05174156	Advanced Esopha...	Combination the...	18 Years - 75 Years	Sixth Affiliated Hospital, Sun Yat-sen University

Spots Global Cancer Trial Database for advanced esophageal cancer