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NCT Number: NCT06907602

Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • T staging evaluation is T1/T2
  • PET/CT and other evaluations show distant metastasis (M1)
  • Planned pregnancy or patients during pregnancy or lactation
  • 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
  • Potential diseases that may affect patients' ability to receive planned treatment, such as drug allergies
  • Acute infectious diseases requiring systemic treatment
  • Previous HIV, HBV, or HCV infections
  • Previously received stem cell or solid organ transplantation

Treatment and study plan

Chemotherapy

Drug

carboplatin plus nab-paclitaxel

Immunotherapy (pembrolizumab)

Drug

Pembrolizumab

Radiotherapy

Radiation

40-45Gy/20fx,5 times a week

Primary outcomes

  1. Pathological response

    Time frame: After surgery

    Postoperative pathology according to CAP classification.

  2. 2-year and 5-year overall survival

    Time frame: 2 years and 5 years after therapy

    overall survival after 2 years and 5 years

Secondary outcomes

  1. Adverse effect incidence

    Time frame: 1 years after therapy

    Adverse effect according to CTCAE and RTOG criteria

  2. R0 resection rate

    Time frame: After surgery

  3. postoperative complications

    Time frame: After surgery

    postoperative complications according to Clavien-Dindo classification

  4. 2-year and 5-year disease-free survival

    Time frame: 2 years and 5 years after therapy

    disease-free survival after 2 years and 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Military 301 Hospital
  • Peking University Cancer Hospital & Institute

Registry information

Official study title

Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Clinical Study

Acronym: ONTRESCC

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Apr 2, 2025
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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