NCT05984342

Brief Summary

Esophageal cancer is one of the most common malignancies in China, and esophageal squamous cell carcinoma (ESCC) is the predominant histological type. Surgical resection is still a standard therapeutic approach for patients with resectable ESCC, but the prognosis is still disappointing. Although neoadjuvant chemoradiotherapy plus surgery is currently recommended for patients with locally advanced ESCC, it is still an infrequently used procedure in China. The efficacy of adjuvant therapy on ESCC is still controversial. Recently, the CheckMate 577 trial showed that adjuvant nivolumab therapy could improve DFS for patients with residual disease after neoadjuvant chemoradiotherapy plus surgery. However, no optimal postoperative adjuvant therapy was recommended for patients with ESCC received upfront surgery. We designed a prospective randomized controlled tial to study whether immunotherapy could be used with chemotherapy after surgery to improve overall survival in these patients. The primary endpoint of the study is disease free survival, with secondary endpoints of overall survival, safety and toxicity, and quality of life.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
38mo left

Started Aug 2023

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Aug 2023Jun 2029

First Submitted

Initial submission to the registry

August 2, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

August 2, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Expected
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

1.9 years

First QC Date

August 2, 2023

Last Update Submit

August 2, 2023

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

esophageal squamous cell carcinomaimmunotherapychemotherapysurgeryadjuvant therapy

Outcome Measures

Primary Outcomes (1)

  • disease-free survival rate

    disease free survival after surgery

    1 years after surgery

Secondary Outcomes (1)

  • Rate of adverse events

    within 6 months

Study Arms (1)

Adjuvant Chemotherapy in Combination With Immunotherapy

EXPERIMENTAL

Adjuvant Chemotherapy in Combination With Tislelizumab was used in patients with Lymph Node-Positive Esophageal Squamous Cell Carcinoma after surgery

Drug: Tislelizumab

Interventions

TislelizumabDRUG

Adjuvant Chemotherapy （nab-paclitaxel 260mg/m2 d1 plus Cisplatin 75mg/m2 d1 or 25mg/m2 d1-3) in combination with Tislelizumab (200 mg Q3W)

Also known as: nab-paclitaxel, Cisplatin
Adjuvant Chemotherapy in Combination With Immunotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18 and 70 years
  • Untreated before surgery (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy)
  • Histologically documented squamous cell carcinoma of the thoracic esophagus with positive lymph nodes （T1-3N1-3M0）
  • undergoing radical esophagectomy
  • ECOG (Eastern Cooperative Oncology Group) : 0-1
  • No recurrent disease before adjuvant therapy
  • Normal hemodynamic indices before the recruitment
  • Able to understand this study and have signed informed consent

You may not qualify if:

  • previous or concurrent malignancy
  • Interstitial lung disease
  • Requiring systemic treatment with either corticosteroids or other immunosuppressive medications
  • Known or suspected allergy to chemotherapeutic drugs or Tislelizumab
  • Active autoimmune disease
  • Active hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, 515031, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

tislelizumab130-nm albumin-bound paclitaxelCisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 2, 2023

First Posted

August 9, 2023

Study Start

August 2, 2023

Primary Completion

June 30, 2025

Study Completion (Estimated)

June 30, 2029

Last Updated

August 9, 2023

Record last verified: 2023-08

Locations

CN(1)