Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 70

Combining chemotherapy with Tislelizumab for esophageal cancer after surgery

Official title: Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma

Run by Affiliated Cancer Hospital of Shantou University Medical College · NCT05984342 · Data updated 2026-11-12

This study is testing if combining an immunotherapy drug called Tislelizumab with chemotherapy can help people with esophageal cancer live longer after surgery.

More Esophageal Squamous Cell Carcinoma trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment50 (estimated)
SponsorAffiliated Cancer Hospital of Shantou University Medical College
Academic / other
Drugs / interventionsTislelizumab, chemotherapy, immunotherapy, nivolumab
Locations1 site (Shantou, Guangdong)
StatusRecruiting
StartedAugust 2, 2023
Main results expectedJune 30, 2025
Study endsJune 30, 2029
Registry record updatedAugust 9, 2023
Trial IDNCT05984342 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 70 with untreated, histologically confirmed ESCC and positive lymph nodes who are undergoing radical esophagectomy.

Probably not a fit

Patients with previous malignancies, active autoimmune diseases, or those requiring immunosuppressive treatments may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of combining Tislelizumab, an immunotherapy drug, with chemotherapy as an adjuvant treatment for patients with lymph node-positive esophageal squamous cell carcinoma (ESCC) following radical surgery. The study aims to determine if this combination can improve overall survival rates in patients who have undergone surgery for ESCC. Participants will be randomly assigned to receive either the combination therapy or standard care, and their outcomes will be monitored to assess the efficacy of the treatment. The trial is particularly relevant given the poor prognosis associated with ESCC and the lack of optimal postoperative therapies currently available.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates for patients with lymph node-positive ESCC after surgery.

How similar studies have gone: Previous studies, such as the CheckMate 577 trial, have shown success with similar immunotherapy approaches, indicating potential for this method.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

1. previous or concurrent malignancy
2. Interstitial lung disease
3. Requiring systemic treatment with either corticosteroids or other immunosuppressive medications
4. Known or suspected allergy to chemotherapeutic drugs or Tislelizumab
5. Active autoimmune disease
6. Active hepatitis
7. Those whom the investigator considered unsuitable for inclusion

Where it's running

  • Cancer Hospital of Shantou University Medical College
    Shantou, Guangdong, China
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.