Using sintilimab after surgery for esophageal cancer
Official title: A Clinical Study of Sintilimab as Adjuvant Therapy in Node-positive Esophageal Squamous Cell Carcinoma After Radical Surgery Without Neoadjuvant Therapy
Run by Zhejiang Cancer Hospital · NCT06190639 · Data updated 2026-11-12
This study tests if a medication called sintilimab can help prevent cancer from coming back in people who have had surgery for esophageal cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 31 (estimated) |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, prednisone, sintilimab |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | October 25, 2023 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2027 |
| Registry record updated | January 5, 2024 |
| Trial ID | NCT06190639 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with histologically confirmed T1-3N+M0 thoracic esophageal squamous cell carcinoma who have undergone radical resection within the last 4-12 weeks.
✕Probably not a fit
Patients with non-node-positive esophageal cancer or those who cannot tolerate radical surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the efficacy and safety of sintilimab as an adjuvant therapy for patients with node-positive esophageal squamous cell carcinoma following radical surgery. Participants will receive sintilimab 200 mg once on day 1 and then every 21 days. The study aims to determine how effective sintilimab is in preventing cancer recurrence in these patients. All participants must be disease-free and meet specific health criteria before enrollment.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and reduce the risk of cancer recurrence for patients with node-positive esophageal cancer.
How similar studies have gone: Other studies have shown promising results with similar immunotherapy approaches in treating esophageal cancer, suggesting potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Signed an Informed Consent Form
2. Participant type and target disease characteristics:
* ECOG PS 0-1
* Histologically confirmed T1-3N+M0 thoracic esophageal squamous cell cancer (AJCC 8th)
* can tolerate radical resection of esophageal cancer
* Resection must be performed within 4-12 weeks prior to enrollment
* All participants must be confirmed disease-free by physical and imaging examinations within 4 weeks prior to enrollment. Imaging examinations must include CT/MRI scans of the neck, chest and abdomen.
* All baseline laboratory tests will be evaluated as required and results should be available within 28 days prior to enrollment. Laboratory test values must be selected according to the following criteria (CTCAE V5.0):
1. WBC ≥2000/μL;
2. Neutrophils ≥1500/μL;
3. Platelets ≥100 x 103/μL;
4. Hemoglobin ≥9.0 g/dL;
5. Creatinine: Serum creatinine ≤1.5 x above normal (ULN) or creatinine removal rate \> 50mL/ min (Cockcroft/Gault formula);
6. AST ≤3 x ULN;
7. ALT ≤3 x ULN;
8. Total bilirubin ≤1.5 x ULN (except for subjects with Gilbert syndrome, where total bilirubin must be \< 3 x ULN);
3. Age and fertility status:
* Age ≥18 years old
* Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity of HCG is 25 IU/L or equivalent) within 24 hours before starting study treatment.
* Women must be non-breastfeeding
Exclusion Criteria:
1. Target disease
* The presence of locally advanced unresectable (regardless of stage) or metastatic disease.
* Cervical and abdominal esophageal tumors.
2. Medical history and concurrent diseases
* Complete resection followed by treatment for the removed esophageal cancer (e.g., chemotherapy, targeted drugs, radiation, or biotherapy).
* Participants with ≥ grade 2 peripheral neuropathy
* Participants with active, known, or suspected autoimmune diseases. Participants with type I diabetes, hypothyroidism requiring only hormone replacement therapy, skin conditions that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss), or conditions that are not expected to recur without external irritants, may be enrolled.
* Glucocorticoids are required for 14 days prior to treatment (daily\>10 mg equivalent dose of prednisone) or other immunosuppressive drugs for systemic treatment.
If there is no active autoimmune disease, inhaled or topical steroid hormones are permitted, and daily\>10 mg prednisone equivalent dose of adrenal hormone replacement therapy.
* A known history of testing positive for human immunodeficiency virus (HIV) or a known history of acquired immunodeficiency syndrome (AIDS)
* Participants with a serious or uncontrolled medical condition.
* Radiotherapy, chemotherapy, immunotherapy, esophagectomy, esophagus-gastric junction, and gastric surgery were performed before the trial.
* Participants with severe cardiovascular or pulmonary disease, interstitial pneumonia, or a history of prior interstitial pneumonia.
* Active malignancy within the last 3 years, other than locally curable cancers that have apparently been cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
* Participants with a serious or uncontrolled medical condition
3. Physical and laboratory examination
* Participants were found to have active hepatitis B (Hepatitis B surface antigen \[HBsAg\] positive or hepatitis C virus (HCV) positive (HCV RNA positive) Sex). Participants with prior HBV infection or recovered HBV infection (defined as having hepatitis B core antibodies \[HBcAb\] and no HBsAg) were eligible. HBV DNA must be obtained from these patients before treatment. Participants who are HBV carriers or require antiviral therapy are not eligible to participate. Participants who were positive for HCV antibodies were eligible only if the PCR for HCV RNA was negative.
4. Allergies and adverse drug reactions
* History of allergy or hypersensitivity to study drug ingredients.
* A history of severe hypersensitivity to any monoclonal antibody.
5. Other exclusion criteria
* Participants who do not understand or may not comply with the requirements of the trial
* Participants had an active infection requiring systemic treatment in the 28 days prior to first dosing
* Some obvious diseases that the researchers believe should be excluded from this study
Where it's running
-
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Changchun Wang, MD
- Email: wangcc@zjcc.org.cn
- Phone: 13606520363
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.
-
Combining Sintilimab with Chemotherapy for Esophageal Cancer Treatment
This study is testing if combining a new drug called sintilimab with chemotherapy can help people with advanced esophageal cancer before surgery.
-
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.
-
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.
-
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.
-
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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.