Combining Sintilimab with Chemotherapy for Esophageal Cancer Treatment

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 study evaluates the effectiveness and safety of sintilimab when used alongside chemotherapy (docetaxel, cisplatin, and 5-fluorouracil) as a neoadjuvant treatment for locally advanced esophageal squamous cell carcinoma. It is designed as a single-arm, phase II trial where participants will undergo three cycles of this combined therapy. The primary goal is to assess the pathologic complete response (pCR) rate in patients after treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥18 years old and ≤75 years old
* Esophageal squamous cell carcinoma diagnosed biopsy histopathology
* The primary tumor is located in the middle of the esophagus and T1b-3N1-3M0 /M1 or T3N0M0 diagnosed by CT/MRI/EUS (AJCC 8th)
* At least one measurable lesion
* Eastern cooperative oncology group (ECOG) performance status of 0 to 1
* With adequate organs function

Exclusion Criteria:

* Patients with active malignancy within 5 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer
* Patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula
* Patients who have received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy

Where it's running

• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting

Study contacts

• Study coordinator: Shuoyan Liu
• Email: shuoyanliu2010@163.com
• Phone: 138 0508 8816

Similar studies

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

• Combining sintilimab with chemotherapy for treating esophageal cancer before surgery

  This study is testing if giving a new immunotherapy along with chemotherapy before surgery can help people with esophageal cancer have better outcomes.

  Recruiting Phase 3 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT06563869

• Using sintilimab after surgery for esophageal cancer

  This study tests if a medication called sintilimab can help prevent cancer from coming back in people who have had surgery for esophageal cancer.

  Recruiting Phase 2 Zhejiang Cancer Hospital · Hangzhou, Zhejiang · NCT06190639

• Using Sintilimab to treat advanced esophageal cancer after surgery

  This study is testing if the immunotherapy drug Sintilimab can help people with advanced esophageal cancer who are at high risk of their cancer coming back after surgery.

  Recruiting at 2 sites Phase 3 Henan Cancer Hospital · Zhengzhou, Henan and 1 other locations · NCT05495152

• Radiotherapy target-volume choices in locally advanced esophageal cancer during immunotherapy

  This observational study looks at how doctors outline the radiation area for locally advanced esophageal squamous cell cancer patients treated with radiotherapy and immunotherapy to see which approaches correlate with better outcomes.

  Recruiting Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07858630

• Tafolecimab with chemoimmunotherapy as neoadjuvant treatment for locally advanced colon cancer

  This study tests whether adding tafolecimab to a chemoimmunotherapy regimen helps shrink locally advanced colon cancer before surgery in adults who have pMMR/MSS tumors.

  Recruiting Phase 2 Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Chongqing, Chongqing Municipality · NCT07840677

• Irreversible Electroporation Added to Targeted Therapy and Immunotherapy for Advanced HCC

  This study tests whether adding irreversible electroporation to lenvatinib and sintilimab can help patients with unresectable advanced hepatocellular carcinoma see bigger tumor shrinkage and become eligible for surgery.

  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, No. 1 Shuaifuyuan, Dongcheng District, Beijing, China · NCT07832006

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.