Phase II clinical study for Sintilimab (IBI308) in the maintenance therapy after second-line chemoradiotherapy for local and/or regional recurrent esophageal squamous cell cancer patients

Open, Single-center, Phase II clinical study for Sintilimab (IBI308) in the maintenance therapy after second-line chemoradiotherapy for local and/or regional recurrent esophageal squamous cell cancer patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900027161

Enrollment

Unknown

Registered

2019-11-02

Start date

2019-11-02

Completion date

Unknown

Last updated

2019-11-04

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

Conditions

esophageal cancer

Interventions

case series:Sintilimab (IBI308) in the maintenance therapy

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 75 years old; Written informed consent form being signed; 2. Histologically confirmed esophageal squamous cell Cancer, local and/or regional recurrent patients treated with surgery, chemotherapy or chemoradiotherapy, Suitable for second-line concurrent chemoradiotherapy. If the patients treated with radiotherapy in the first-line treatment, the time after radiotherapy is at least 8 months. 3. Agree to have histologic tumor collected; 4. ECOG 0 or 1, Estimated survival time of at least 8 months; 5. Blood routine examination: hemoglobin >=9 g/dL, absolute neutrophil count (ANC) >=1.5 x 10^9/L, platelets >=100 x 10^12/L.

Exclusion criteria

Exclusion criteria: 1. women who are pregnant or breast-feeding; 2. Patients who can not tolerate the concurrent chemoradiotherapy due to severe symptoms, risk of esophageal fistula and so on; 3. serious treatment-related toxicities before enrollment; 4. widely metastatic patients unsuitable for radiotherapy; 5. Patients who have previously received immunological checkpoint inhibitor drugs; 6. patients who are not suitable for chemoradiotherapy due to severe heart, lung, liver, kidney dysfunction, hematopoietic system diseases, immune system diseases, cachexia and so on; 7. Patients with active infection, active tuberculosis infection, previous active tuberculosis infection or positive for Hepatitis B surface antigen (HBsAg), positive for Hepatitis C antibody (HCV-Ab), positive for Acquired immunodeficiency syndrome antibody (Anti-HIV) or positive for Treponema pallidum antibody (TP-Ab); 8. Progression of patients who received second-line concurrent chemoradiotherapy; 9. Patients with other malignant tumors.

Design outcomes

Primary

Measure	Time frame
treat-related adverse event;the initial tumor response;	—

Countries

China

Contacts

Public ContactBaosheng Li

Shandong Cancer Hospital

baoshli163@163.com+86 13954168847

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026