Neoadjuvant chemoimmunotherapy followed by endoscopic removal for esophageal squamous cell carcinoma

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 single‑center, prospective, single‑arm phase 1 study gives adults with potentially resectable esophageal squamous cell carcinoma at least two 3‑week cycles of tislelizumab (200 mg on Day 1) combined with carboplatin (AUC 3–5 on Day 1) and nab‑paclitaxel (≤260 mg/m2 on Day 1), with routine safety monitoring. About 3–4 weeks after completing treatment, patients undergo clinical reassessment with endoscopy, endoscopic ultrasound, and CT or PET/CT to measure tumor response by RECIST 1.1 and to evaluate nodal or distant spread. If a clinical complete response is seen without obvious nodal disease, patients may undergo endoscopic resection to preserve the esophagus; otherwise they proceed to standard surgery or chemoradiation per clinical judgment. Key eligibility includes biopsy‑proven ESCC staged T1b–3 N0 M0 with tumor ≤5 cm and occupying less than two‑thirds of the luminal circumference, age 18–80, ECOG 0–1, and no prior antitumor therapy.

Why it matters

Who can join: the full rules

Cohort A - Potentially resectable ESCC:

Inclusion Criteria：

1. Age range: 18-80 years old;
2. Patients diagnosed with esophageal squamous cell carcinoma (ESCC) through histopathological examination of biopsy tissues from the primary tumor;
3. Patients with potentially resectable esophageal cancer confirmed by imaging and endoscopic examinations (T1b-3, N0, M0, with a tumor size not exceeding 5 cm and occupying less than 2/3 of the luminal circumference); Patients who have not received any antitumor treatment, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, and targeted therapy;
4. Patients with a preoperative Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
5. Patients with a preoperative American Society of Anesthesiologists (ASA) physical status classification of I-III;
6. Female patients of reproductive age should have a negative pregnancy test and be willing to use effective contraceptive methods during the study period;
7. Patients who have signed the informed consent form.

Exclusion Criteria:

1. Patients with potential tracheoesophageal fistula or aortoesophageal fistula;
2. Patients with severe malnutrition or requiring tube feeding;
3. Patients with other malignancies that have not been cured within the past 2 years (except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix);
4. Patients with active autoimmune diseases or a history of autoimmune diseases or symptoms that require systemic corticosteroid treatment or anti-autoimmune drug therapy;
5. Immunocompromised patients, or patients who are still receiving systemic steroids (prednisone \> 10 mg/day or equivalent) or other forms of immunosuppressive therapy within 7 days before the first dose of neoadjuvant therapy in this study;
6. Patients with active infections requiring systemic treatment within 7 days before the first neoadjuvant therapy in this study;
7. Patients with a history of allogeneic organ or stem cell transplantation;
8. Patients with allergies to drugs or related components involved in this study;
9. Patients who are currently participating in any other clinical study.

Cohort B - Surgery-contraindicated ESCC:

Inclusion Criteria:

1. Individuals aged above 18 years;
2. Patients diagnosed with esophageal squamous cell carcinoma through histopathological examination of biopsy tissues from the primary tumor;
3. Patients with esophageal cancer deemed as surgically contraindicated (including those with cervical esophageal cancer, surgical contraindications, those who refuse surgery, or those considered high-risk for esophagectomy, defined as having at least one of the following characteristics: (1) age over 75 years, (2) Charlson comorbidity index \>= 2, (3) presence of moderate lung dysfunction, (4) malnutrition (with a body mass index below 18 kg/m\^2)), with a clinical staging of cT1b-3N0M0, a tumor size not exceeding 5 cm, and occupying less than 2/3 of the luminal circumference;
4. Patients who have not undergone any antitumor treatment, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, and targeted therapy;
5. Female patients of reproductive age should have a negative pregnancy test and be willing to adopt effective contraceptive measures during the study period;
6. Patients who have signed the informed consent form.

Exclusion Criteria:

1. Patients with allergies to the drugs or related components involved in this study;
2. Patients who are currently participating in any other clinical study.

Where it's running

• Shanghai Zhongshan Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Li-Yun Ma, MD
• Email: maly14@fudan.edu.cn
• Phone: +86 13162909612

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

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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.