Tislelizumab for consolidation therapy in patients with pathologically residual esophageal squamous cell carcinoma after concurrent chemoradiotherapy: a multicenter, randomized phase 2 clinical trial

Tislelizumab versus Observation for consolidation therapy in patients with pathologically residual esophageal squamous cell carcinoma after concurrent chemoradiotherapy: a multicenter, randomized phase 2 clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200063345

Enrollment

Unknown

Registered

2022-09-05

Start date

2022-09-01

Completion date

Unknown

Last updated

2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal squamous cell carcinoma

Interventions

chemotherapy and tislelizumab group:chemotherapy and tislelizumab

chemotherapy group:chemotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years old, fully understand the content and risk of this clinical trial, sign the informed consent form. 2. Stage II-IVA and stage IVB esophageal squamous cell carcinoma with only supraclavicular and / or retroperitoneal lymph node metastasis (AJCC 8th edition). 3. Concurrent chemoradiotherapy is defined as radiotherapy dose >= 50Gy and receiving more than or equal to one cycle of chemotherapy during radiotherapy. 4. Non-PD patients with esophageal squamous cell carcinoma after concurrent chemoradiotherapy. 5. Patients with pathological residue (primary tumor or lymph nodes) after concurrent chemoradiotherapy. 6. The ECOG score was 0 or 1, and the expected survival time was more than 3 months.

Exclusion criteria

Exclusion criteria: . Patients with = 3 grade radiation pneumonia during concurrent chemoraidotherapy. 2. patients with severe heart, lung, liver, kidney dysfunction, hematopoietic system diseases, immune system diseases, cachexia and other intolerable immune consolidation therapy. 3. Active infection, active pulmonary tuberculosis infection, previous active pulmonary tuberculosis infection, hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), acquired immunodeficiency syndrome antibody (Anti-HIV) and anti-Treponema pallidum antibody (TP-Ab) were positive. 4. Patients with other tumors combined within 5 years. 5. Breastfeeding or pregnant women. 6. 6. other conditions that the investigator considers inappropriate for enrollment.

Design outcomes

Primary

Measure	Time frame
progression-free survival;	—

Countries

China

Contacts

Public ContactBaosheng Li

Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences

bsli@sdfmu.edu.cn+86 531 67626161

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026