NCT06152978Not yet recruitingPhase 2
A Perioperative Sintilimab and Chemotherapy in Esophageal Squamous Cell Carcinoma
A Prospective, Open-label, Randomized, Phase II Study of the Efficacy and Safety of Sintilimab Combined With Chemotherapy Versus Chemotherapy in Perioperative Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma (ECTOP-2006).
Source: ClinicalTrials.gov · Last updated 1 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study is aimed to evaluate the efficacy and safety of sintilimab combined with chemotherapy versus chemotherapy in perioperative treatment of locally advanced esophageal squamous cell carcinoma.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 182 (estimated)
- First submitted
- 1 Nov 2022
- Start date
- 15 Dec 2023
- Primary completion date
- 15 Dec 2025
- Lead sponsor
- Fudan University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06152978
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 182
- From 15 Dec 2023 to the primary completion date, 15 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous subtotal gastrectomy.
- 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.
Other illness
- Patients with active malignancy within 2 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.
- With signs of pre-esophageal perforation. With any active autoimmune disease or has a history of autoimmune disease.
Other
- With metastases or unresectable primary lesion suggested by imaging before treatment.
Who the study is looking for
- Esophageal squamous cell carcinoma suggested by gastroscopic histopathology.
- The primary tumor is located in the middle and lower of the esophagus.
- cT2-4aN0～3M0 or cT1N+M0 diagnosed by enhanced CT/MRI scan.
- Tumor was evaluated as resectable by surgeon before neoadjuvant therapy.
- Eastern cooperative oncology group (ECOG) performance status of 0 to 1.
- Can eat semi-liquid food.
- Less than 20% body weight loss within 6 months prior to enrollment.
- Sign the consent form before treatment and be able to comply with the relevant procedures such as treatment and visits stipulated in the protocol.
- With adequate organs function 1 week before enrollment and tolerable to chemotherapy and surgery.
- Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age should take effective contraceptive measures throughout the treatment period and 180 days after the last dose of the test drug.
- Agree and be able to provide archived or fresh pathological tissue and whole blood, urine and fecal samples for biomarker testing.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.