NCT06907602RecruitingPhase 2/3
Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma
Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Clinical Study
Source: ClinicalTrials.gov · Last updated 2 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Our previous study, a single-center, prospective, single-arm Phase II study (Keypoint001) has demonstrated the efficacy and safety of neoadjuvant chemotherapy combined with immunotherapy in locally advanced (cT3-4N+M0) esophageal squamous cell carcinoma. The results show that the pathological complete response rate (pCR) reaches 35%, and the major pathological response rate is over 70%, which is much higher than that of patients receiving chemotherapy alone. Meanwhile, no severe adverse drug reactions have been found in terms of safety, so this treatment regimen is safe and reliable. However, the cycle of neoadjuvant immunotherapy is still under exploration. Currently, the mainstream research centers adopt a regimen of 2 to 4 cycles. The exploration results of our center have found that most patients' conditions can be further alleviated after 4 cycles compared with after 2 cycles, but there are still a small number of patients with no obvious remission. Therefore, we consider observing whether patients with no obvious remission can achieve a better pathological response rate through further radiotherapy.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 27 Mar 2025
- Start date
- 12 Jan 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06907602
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 120
- From 12 Jan 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous chemotherapy, radiation therapy, or immunotherapy
- Previous severe coronary heart disease and heart failure (NYHA grade III/IV)
- Previous pulmonary interstitial fibrosis or severe pulmonary dysfunction that cannot tolerate surgery
- Previous autoimmune disease requiring systemic treatment within 2 years
- Previous immunodeficiency diseases or the need for systemic steroid replacement therapy
- Previous motor or sensory neurotoxic diseases
- Previous mental illness
- Previous HIV, HBV, or HCV infections
- Previously received stem cell or solid organ transplantation
Other illness
- Potential diseases that may affect patients' ability to receive planned treatment, such as drug allergies
- Acute infectious diseases requiring systemic treatment
Other
- T staging evaluation is T1/T2
- PET/CT and other evaluations show distant metastasis (M1)
- Planned pregnancy or patients during pregnancy or lactation
Who the study is looking for
- male or female
- Age ≥ 18 years old
- Pathological confirmation of esophageal squamous cell carcinoma
- Endoscopic ultrasound, enhanced CT scan of the neck, chest, and abdomen, and esophageal magnetic resonance imaging evaluate as T3 or resectable T4 PET/CT、 Cervical, thoracic, and abdominal enhanced CT evaluation of N0 or N+
- No clear distant metastasis (M0) and only cervical or supraclavicular lymph node metastasis (M1a)
- Tumor longitudinal diameter ≤ 10cm
- The tumor did not involve the dentate line
- ECOG score 0 or 1
- No hematological diseases, no liver or kidney dysfunction
- Absolute neutrophil count ≥ 1.5 × 109/L
- Platelets ≥ 100 × 109/L
- Hemoglobin ≥ 11g/L
- ALT ≤ 2 times the upper limit of normal value
- TBil ≤ 1.5 times the upper limit of normal value
- Creatinine clearance rate (Cockroft) ≥ 50ml/min
- Obtain informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.