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NCT Number: NCT06421376

Induction Chemoimmunotherapy Combined With Chemoradiotherapy in Esophageal Cancer

Although unprecedented advances have been made in the field of esophageal cancer in recent decades, the prognosis for patients with locally advanced esophageal squamous cell carcinoma (ESCC) remains extremely poor, accounting for 30-40% of overall survival at 5 year. In recent years, multimodal treatments have proven to be an appropriate therapeutic approach for locally advanced ESCC. Recently, immunotherapy developed rapidly. The purpose of this study was to observe the efficacy and safety of cardonilizumab combined with chemoradiotherapy in the treatment of locally advanced ESCC.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anyang Cancer Hospital, Anyang, Henan, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-80 years old;
  • Eligible patients were histologically confirmed esophageal squamous cell carcinoma;
  • Eligible patients were proven locally advanced ESCC (cT1-2N1-3M0-1, cT3/T4N0-3M0-1, M1 was limited to supraclavicular lymph node metastasis)diagnosed by computed tomography [CT] and/or endoscopic ultrasonography [EUS] according to the American Joint Committee on Cancer (AJCC) 8th edition staging system;
  • ECOG PS score: 0~1;
  • Main organs and bone marrow function are normal: routine blood tests: hemoglobin (Hb) ≥100g/L ; absolute neutrophil count (NEUT)≥1.5×109/L; platelets (PLT) ≥100×109/L; white blood cell (WBC)≥3.5×109/L,biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×UNL; serum total bilirubin (TBIL) ≤1.5×UNL; serum creatinine ( Cr) 1.0×1.5UNL, and BUN≤1.0×UNL;

Exclusion criteria

  • Those combined with other primary malignant tumors other than esophageal cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
  • patients who had previously received other treatments
  • At the time of diagnosis, there were distant and hematogenous metastases beyond the supraclavicular lymph node region, including retroperitoneal multiple lymph node metastasis, bone metastasis, brain metastasis, lung metastasis, liver metastasis, malignant pleural effusion and ascites
  • Those who already have esophageal perforation or are at high risk of esophageal perforation
  • Patients whose tumors invade close to large blood vessels and are at risk of bleeding in the
  • there are active infections, such as active tuberculosis and hepatitis
  • There are contraindications to immunotherapy.
  • Pregnant or lactating women and women of childbearing age do not take reliable contraceptive measures
  • Combined with serious cardiovascular diseases, such as uncontrolled heart failure, coronary heart disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or a history of myocardial infarction within the past 6 months; and those combined with other uncontrolled acute and chronic diseases such as hypertension and diabetes.
  • Violation of inclusion and exclusion criteria, or other reasons that the researcher believes cannot continue the study of drug treatment.

Treatment and study plan

cardonilizumab

Drug

Two cycles of Inductive therapy: nab-paclitaxel 250mg/ m2+cisplatin 75mg/ m2+Cardonilizumab 10mg/kg,ivgtt,3 weeks per cycle for 2 cycles

Chemoradiotherapy ±immunotherapy

Radiation

Chemoradiotherapy ± immunotherapy:

  • PTV: 50-50.4Gy/1.8-2Gy/25-28fractions ②nab-paclitaxel 100mg+cisplatin 25mg/ m2, d1, every 7 days for 3-5 weeks ③Cardonilizumab 10mg/kg,ivgtt,3 weeks per cycle for 2 cycles

Radical surgery

Procedure

Surgery was evaluated after concurrent chemoradiotherapy according to patients willing and the surgeons' assessment. If patients were accessed with unresectable disease after radiotherapy or refused to receive surgery, Cardonilizumab would be administered for 2 years or until disease progression.

Primary outcomes

  1. Event-free survival

    Time frame: 1-year

    Time from treatment initiation to locoregional or distant recurrence, or death from any cause.

Secondary outcomes

  1. Overall survival

    Time frame: 1-year

    The 1-year OS rate was defined as the proportion of patients who still alive within one year from treatment initiation.

  2. Adverse events

    Time frame: 1-year

    In terms of adverse events of radiation, chemotherapy and immunotherapy

  3. Locoregional recurrence free survival

    Time frame: 1-year

    The 1-year rate was defined as the proportion of patients who did not have any locoregional recurrence from treatment initiation.

  4. Distant metastasis free survival

    Time frame: 1-year

    The 1-year rate was defined as the proportion of patients who did not have any distant metastasis from treatment initiation.

Study contacts

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

Xin Wang, M.D.

CONTACT

[email protected]

+8601087787635

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

Efficacy and Safety of Inductive Chemoimmunotherapy Followed by Chemoradiotherapy With or Without Surgery in Locally Advanced Esophageal Squamous Cell Cancer: a Single-arm, Prospective, Phase II Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 20, 2024
Registry last updated
May 30, 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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