Clinical trial · Interventional
Study of PD-1 Antibody Combined With Chemoradiotherapy in Oligometastatic Esophageal Cancer
A Phase II Study of PD-1 Antibody Combined With Chemoradiotherapy in Oligometastatic Esophageal Squamous Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Chemoradiotherapy(CRT) is the main treatment for esophageal cancer patients with recurrent desease,and checkpoint blockade (PD-1) have been shown to be effective in advanced esophageal cancer. Therefore, PD-1 combined with chemoradiotherapy (CRT)may further improve the efficacy and become a new method for the treatment of esophageal cancer.This study intends to conduct a single-arm, prospective clinical study, aiming to evaluate the safety and efficacy of PD-1 combined with chemoradiotherapy(CRT) in patients with oligometastatic esophageal squamous cell carcinoma.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemoradiotherapy | — | UNRESOLVED | — |
| Esophagus Cancer | — | UNRESOLVED | — |
| Immunotherapy | — | UNRESOLVED | — |
| Oligometastatic Disease | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Albumin-Bound Paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Chemoradiation | Radiation | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
| PD-1 antibody | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemoradiotherapy Combined With PD-1 Antibody
- description
- The arm received chemoradiotherapy, 50-60Gy (BED) was given (1.8-2 Gy or 3-4Gy once daily , 5 days a week) to recurrent sites combined with chemotherapy(Cisplatin 75 mg/m2/day 1, and albumin paclitaxel 150 mg/m2/day 1 , every 3 weeks, 2 cycles ).PD-1 antibody (Tislelizumab) was performed simultaneously with concurrent chemoradiotherapy (Triprizumab 200mg,d1,every 3 weeks,2 cycles). After completion of chemoradiotherapy, PD-1 antibody was given continuously with 2-4 cycles of chemotherapy (the same regimen with concurrent chemotherapy) until 1 year or desease progression.
- interventionNames
- Drug: PD-1 antibody
- Radiation: Chemoradiation
- Drug: Albumin-Bound Paclitaxel
- Drug: Cisplatin
Primary outcomes (1)
- measure
- Locoregional control rate
- timeFrame
- 3 year
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: •≥18 years; * Esophageal squamous cell carcinomas; * After radical treatment including surgery or definitive chemoradiotherapy * Definition of oligometastases:≤3 metastases, including tumor beds and recurrent anastomotic sites;regional lymph node is defined as one metastatic site(AJCC8th, supraclavicular, mediastinal, abdominal);metastases lesion in liver, lung, bone and brain is no more than 1. * Karnofsky performance status(KPS)≥ 70; * No immunotherapy were performed after recurrence; * a white-cell count of at least 3500G/L, a hemoglobin concentration of at least 100 g/L, a platelet count of at least 100,000/lL, aspartate aminotransferase and alanine aminotransferase levels of within 1.5 times the upper limit of normal, a serum bilirubin level of 1.5 mg/dL or less, a creatinine level of 1.1 mg/dL or less; * Hepatitis virus indicators: normal or hepatitis virus DNA titer less than 500 at the same time in an infectious disease hospital, and with the consent of the doctor can be treated; Exclusion Criteria: * Pregnancy, possible pregnancy, or breast-feeding; * Psychological, family, social and other factors lead to uninformed consent; * An esophageal mediastinal fistula and/or an esophageal tracheal fistula prior to treatment; * Serious complications such as ischemic heart disease, arrhythmias, or other types of heart disease requiring treatment; liver cirrhosis; interstitial pneumonia or pulmonary fibrosis; active gastrointestinal bleeding; mental disorders being treated with antipsychoticagents or requiring treatment; * Controlled diabetes mellitus; * A history of autoimmune disease, autoimmune disease (such as colitis, hepatitis, hyperthyroidism, including but not limited to these disease or syndrome) and a history of immune deficiency, including test positive for HIV, or has other acquired, congenital immunodeficiency disease, or have a history of organ transplantation and the history of allogeneic bone marrow transplantation; * A history of interstitial lung disease and a history of non-infectious pneumonia; * Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 Copies /mL), hepatitis C ;(positive HCV antibody and HCV-RNA above the detection threshold of the assay) * Any situation that is unstable or may compromise patient safety and compliance ; * Active infections, such as active tuberculosis, are present;
References
Publications (0)
Data not yet available