Neoadjuvant CTLA-4 and PD-1 blockade with chemoradiotherapy for locally advanced ESCC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm phase II study enrolling patients with resectable locally advanced thoracic ESCC. Participants receive induction therapy with a CTLA-4 inhibitor and a PD-1 inhibitor, followed by concurrent chemoradiotherapy with continued PD-1 inhibition. IMRT delivers 40 Gy in 20 fractions, and radical esophagectomy with two-field lymph node dissection is planned 6–8 weeks after neoadjuvant therapy. The trial primarily aims to assess efficacy and safety of the triplet regimen in the neoadjuvant setting. The study is conducted at a single center with strict eligibility criteria and comprehensive pre-treatment assessments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histologically confirmed resectable thoracic esophageal squamous cell carcinoma (ESCC); pretreatment clinical stage of T1-4aN1-3M0 or T3-4aN0M0 per the 8th edition of UICC staging system.
2. Treatment-naive patients without prior anti-tumor therapy.
3. Expected survival duration \> 6 months.
4. Aged between 18 and 75 years, either male or female.
5. Adequate function of major vital organs meeting the following laboratory criteria:

   1. White blood cell (WBC) ≥4.0×10⁹/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L;
   2. Platelet count ≥100×10⁹/L;
   3. Hemoglobin ≥9 g/dL;
   4. Serum albumin ≥2.8 g/dL;
   5. Total bilirubin ≤1.5 × ULN; ALT, AST and/or ALP ≤2.5 × ULN;
   6. Serum creatinine ≤1.5 × ULN, or creatinine clearance \>60 mL/min.
6. Eastern Cooperative Oncology Group (ECOG) PS score: 0-1.
7. Capable of understanding the study protocol and signing written informed consent.
8. Absence of severe complications including active massive gastrointestinal hemorrhage, perforation, jaundice, bowel obstruction, or non-malignant fever \>38℃.
9. Female and male patients of childbearing potential must use effective contraception throughout relevant study period.
10. Good treatment compliance and availability for scheduled follow-up of efficacy and adverse events per study protocol.

Exclusion Criteria:

1. Patients who have received prior anti-tumor therapies including chemotherapy, radiotherapy, surgery, immunotherapy, etc.
2. Patients with known or suspected hypersensitivity to any components of CTLA-4 inhibitors, sintilimab or other monoclonal antibodies, as well as chemotherapeutic agents (nab-paclitaxel and cisplatin).
3. Patients with pre-existing hemorrhagic disorders.
4. Patients with unresectable disease due to other uncontrollable conditions.
5. Female patients who are pregnant or breastfeeding.
6. Patients lacking capacity to provide informed consent due to psychological, familial or social reasons.
7. Patients with peripheral neuropathy graded ≥ Grade 2 per CTCAE criteria.
8. Patients with a prior history of other malignancies besides esophageal cancer, except for non-melanoma skin cancer, cervical carcinoma in situ, or previously cured early-stage prostate cancer.
9. Patients with more than 10 years of diabetes mellitus and poorly controlled blood glucose.
10. Patients with severe impairment of cardiac, pulmonary, hepatic or renal function, hematological diseases or cachexia that preclude tolerance to chemotherapy, radiotherapy or surgery.
11. Patients with active or past history of autoimmune diseases (including but not limited to colitis, hepatitis, hyperthyroidism), or history of immunodeficiency diseases (HIV positive, other acquired or congenital immunodeficiency disorders), or previous history of solid organ or allogeneic hematopoietic stem cell transplantation.
12. Patients with prior history of interstitial lung disease or non-infectious pneumonia.
13. Subjects with active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL) or active hepatitis C (HCV antibody positive with HCV-RNA above the lower limit of quantification of the assay).

Where it's running

• No.651 Dongfeng East Road,Guangzhou
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Hong Yang
• Email: yanghong@sysucc.org.cn
• Phone: 86-135560405144

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CR-002 study in adults with advanced solid tumors

  This trial tests CR-002 as a single therapy to see if it is safe and tolerable in adults with locally advanced or metastatic solid tumors

  Recruiting at 3 sites Phase 1/2 Crescent Biopharma, Inc. · Austin, Texas and 2 other locations · NCT07909031

• PD-1 inhibitors with local therapy at different timings in oligometastatic ESCC

  This study tests whether giving local radiotherapy at different times around PD-1 inhibitor therapy helps people with oligometastatic esophageal squamous cell carcinoma.

  Recruiting Fudan University · Shanghai, Shanghai Municipality · NCT07697859

• Adebrelimab plus chemotherapy before surgery for borderline-resectable esophageal squamous cell carcinoma

  This trial tests whether adding adebrelimab to chemotherapy given before surgery can shrink borderline-resectable ESCC enough to allow curative tumor removal.

  Recruiting Phase 2 Sun Yat-sen University · Guangzhou, Guangdong · NCT07638436

• Adebrelimab with neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma

  This study tests whether giving adebrelimab with paclitaxel, carboplatin, and short-course radiotherapy before surgery helps ESCC patients.

  Recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07595770

• Starting chemo plus PD-1 immunotherapy before radiation versus giving chemo during radiation for unresectable locally advanced esophageal squamous cell carcinoma

  This trial sees if giving three cycles of chemotherapy with a PD-1 immunotherapy before radiation, followed by maintenance immunotherapy, works better than giving chemotherapy at the same time as radiation followed by the same maintenance for people with unresectable locally advanced esophageal squamous cell carcinoma.

  Recruiting Phase 2 Second Affiliated Hospital of Zunyi Medical University · Zunyi, Guizhou · NCT07559045

• KC1036 plus a PD-1 antibody and platinum chemotherapy for first-line advanced esophageal cancer

  This trial will test whether adding the oral drug KC1036 to a PD-1 antibody (toripalimab) with paclitaxel and cisplatin helps people with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma as first-line treatment.

  Recruiting Phase 2 Beijing Konruns Pharmaceutical Co., Ltd. · Beijing · NCT07481058

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.