Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Neoplasms

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

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Tislelizumab

Fluorouracil

Albumin-Bound Paclitaxel

Cisplatin

Antineoplastic Agents, Immunological

LBL-007 in combination with tislelizumab plus chemotherapy doublet.

LBL-007 will be administered at a standard dose intravenously.

LBL-007

Tislelizumab will be administered at a standard dose intravenously.

Doublet 1: cisplatin + 5-fluorouracil Doublet 2: cisplatin + paclitaxel

Choice of chemotherapy doublet will be determined by the investigator and will be administered at standard doses intravenously.

Chemotherapy Doublet

Study Director

This is a randomized, open-label study to compare how well LBL-007 works in combination with tislelizumab and chemotherapy versus tislelizumab and chemotherapy when given as the first-line treatment in participants with inoperable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC).

A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

A Phase 2, Randomized, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of LBL-007 in Combination With Tislelizumab Plus Chemotherapy as First-Line Treatment in Patients With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Percentage of participants whose best overall response (BOR) is complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.

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.

Time from the first determination of an overall response until the first documentation of progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first.

Percentage of participants whose BOR is CR, PR, and stable disease as assessed by the investigator per RECIST v1.1.

Number of participants with AEs, including findings from physical examinations, electrocardiograms, and laboratory assessments according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.

BeiGene

Immunomodulating Agents

Immunologic Factors

Radiotherapy:Intensity-modulated radiotherapy (IMRT) Immunotherapy: Toripalimab

95% PGTV56-60Gy/28-30 fractions, 2Gy/1 fractions; 95% PTV50.4-54Gy/28-30 fractions, 1.8Gy/1 fractions; 5 days a week; 6 weeks.

Radiotherapy

Toripalimab (200 mg, intravenously infused) will be administered as the maintenance treatment every 3 weeks within 4 weeks after the completion of radiotherapy for 1 years or until progression, intolerable toxicity, or physician/patient decision

Toripalimab

Zhifeng Tian, M.D

Wencai Li, M.D

The incidence and mortality of esophageal squamous cell carcinoma are at the forefront in China.Most part of patients are elderly. Concurrent chemoradiotherapy is the standard treatment for unresectable locally advanced esophageal squamous cell carcinoma. Most elderly patients cannot tolerate concurrent chemotherapy because of complications and other reasons. Immunotherapy has definite efficacy and low toxicity in advanced esophageal squamous cell carcinoma, and the results combined with radiotherapy have also been preliminarily reported. Therefore, it is necessary to further explore the efficacy and safety of radiotherapy combined with immunotherapy in elderly patients with esophageal squamous cell carcinoma.

This is a prospective, multicenter, single-arm, phase Ⅱ clinical study to evaluate the efficacy and safety of radiotherapy alone followed by sequential injection of Toripalimab in elderly patients with unresectable esophageal squamous cell carcinoma who could not accept concurrent chemotherapy.

Immunotherapy After Radiotherapy in Elderly ESCC

Toripalimab After Radiotherapy Alone in Elderly Esophageal Squamous Cell Carcinoma: A Prospective Phase II Clinical Trial

We aim to evaluate the progression-free survival (PFS) of elderly patients with unresectable esophageal squamous cell carcinoma who were unable to accept concurrent chemotherapy and received sequential treatment with Triptolide injection after radiotherapy alone.

Overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence .

Objective response rate (ORR) is defined as the proportion of patients with a complete response(CR) or partial response(PR) to treatment according to RECIST v1.1.

Duration of response (DOR) was determined from date of initial response to PD according to RECIST v1.1.

Time to death or distant metastasis (TTDM) according to RECIST v1.1.

The Central Hospital of Lishui City

Tubulin Modulators

Antimitotic Agents

Paclitaxel 135mg/m2 , D1; Cisplatin 80mg/m2, D1; tislelizumab 200mg D2 ; totally 2-4 cycles

tislelizumab+ Paclitaxel + Cisplatin

Hongjing Jiang, MD，phD

Xiaobin Shang, MD，phD

Hongjing Jiang, MD,PhD

xiaobin shang, MD,PhD

Xiaobin Shang, MD,PhD

Whether the introduction of immunotherapy can transform unresectable esophageal cancer into resectable, or even achieve R0 surgical resection, has not been reported yet. We plan to conduct a prospective, single-center, single-arm phase II clinical study of the safety and efficacy of tislelizumab combined with chemotherapy in the treatment of unresectable esophageal squamous cell carcinoma.

For patients not eligible for R0 resection (defined as locally advanced unresectable esophageal cancer), preoperative treatment can theoretically transform the tumor into a resectable state. The current significance of transformation therapy is to reduce tumor volume and stage to achieve radical resection, eliminate micrometastases, and prevent a postoperative recurrence. There are few studies on the transformation therapy of esophageal squamous cell carcinoma. We plan to conduct a prospective, single-center, single-arm phase II clinical study of the safety and efficacy of tislelizumab combined with chemotherapy in the treatment of T4a/N3 esophageal squamous cell carcinoma.

Conversion of Tislelizumab Combined With Chemotherapy in Unresectable Esophageal Squamous Cell Carcinoma

A Prospective, Single-center, Single-arm Phase II Clinical Study of the Safety and Efficacy of Tislelizumab Combined With Chemotherapy in the Treatment of Unresectable Esophageal Squamous Cell Carcinoma

The percentage of pathologic complete response at resection for patients who has completed the study regimen

Viable tumor comprised ≤ 10% of resected tumor specimens

Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions

DFS is defined as the time interval between the date of enrollment and the date of the first documented evidence of relapse after radical resection at any site or death related to cancer

Time from the enrollment to death of any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma	NCT06010303	Esophageal Canc... Esophageal Squa... Esophageal Squa...	LBL-007 Tislelizumab Chemotherapy Do...	18 Years -	BeiGene
A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma	NCT06010303	Esophageal Canc... Esophageal Squa... Esophageal Squa...	LBL-007 Tislelizumab Chemotherapy Do...	18 Years -	BeiGene
Immunotherapy After Radiotherapy in Elderly ESCC	NCT05791136	Esophageal Squa...	Radiotherapy Toripalimab	75 Years -	The Central Hospital of Lishui City
Conversion of Tislelizumab Combined With Chemotherapy in Unresectable Esophageal Squamous Cell Carcinoma	NCT05449483	Esophageal Squa... Unresectable	tislelizumab+ P...	18 Years - 75 Years	Tianjin Medical University Cancer Institute and Hospital
Immunotherapy After Radiotherapy in Elderly ESCC	NCT05791136	Esophageal Squa...	Radiotherapy Toripalimab	75 Years -	The Central Hospital of Lishui City

Spots Global Cancer Trial Database for esophageal squamous cell carcinoma by ajcc v8 stage