NCT06342167 Efficacy and Safety of Concurrent PD-1 Inhibitor and Radiotherapy With Immunonutrition for Esophageal Squamous Cell Carcinoma
| NCT ID | NCT06342167 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Locally Advanced Esophageal Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 57 participants |
| Start Date | 2024-03-14 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 57 participants in total. It began in 2024-03-14 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
At present, concurrent chemoradiotherapy (cCRT) with platin-based dual-drug regimen is the standard treatment for inoperable, locally advanced esophageal cancer in patients with a good performance status. However, cCRT has substantial toxic effects, and a large number of patients with older age, malnutrition and other morbidities, cannot tolerate cCRT. Several phase II trials showed combining PD-1 inhibitor with definitive cCRT provided encouraging activity and acceptable toxicity in patients with locally advanced esophageal squamous cell carcinoma (LA-ESCC). Therefore, this single-arm, multicenter, phase II trial aims to assess the efficacy and safety of immunotherapy plus radiotherapy with immunonutrition support in patients with LA-ESCC and positive PD-L1 expression who are intolerant to cCRT.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 years or order. 2. Diagnosed with locally advanced or early stage esophageal squamous cell carcinoma by pathological examinations of the primary lesion and imaging examinations, which are not resectable. 3. Confirmed to be unresectable and unable to tolerate synchronous chemoradiotherapy by multidisciplinary consultation, and has not undergone systemic drug therapy in the past. 4. PD-L1 tumor proportion score or combined positive score of ≥1%. 5. At least one measurable lesion on imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 6. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 -2. 7. Expected survival time of more than three months. 8. Adequate organ function defined as the following laboratory indicators: 1. Absolute neutrophil count (ANC) ≥ 1.5×109/L without use of granulocyte colony-stimulating factor in the past 14 days. 2. Platelet count ≥ 100×109/L without blood transfusion in the past 14 days. 3. Hemoglobin \> 9g/dL without blood transfusion or use of erythropoietin-stimulating agents in the past 14 days. 4. Total bilirubin ≤ 1.5×upper limit of normal (ULN). 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN. 6. Creatinine ≤ 1.5×ULN and creatinine clearance calculated using the Cockcroft-Gault formula) ≥ 60 ml/min. 7. Good coagulation function, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5×ULN. 8. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can still be included. 9. Normal cardiac enzyme spectrum (or clinically insignificant laboratory abnormalities as determined by the investigator) 9. Negative pregnancy test (urine or serum) within 3 days before the first dose of study drug for female subjects of childbearing potential. If the urine pregnancy test cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing potential female is defined as postmenopausal for at least 1 year or has undergone surgical sterilization or hysterectomy. 10. Willing to sign the informed consent form. Exclusion Criteria: Subjects with any of the following conditions cannot participate in the study: 1. A high risk of bleeding or perforation due to clear invasion of adjacent organs (large arteries or trachea) by the tumor, or with fistula. 2. Diagnosed with malignancies other than esophageal cancer within 3 years prior to the first dose (excluding cured basal cell carcinoma or squamous cell carcinoma of the skin and/or radically resected carcinoma in situ). 3. Previous immunological or immunomodulatory drugs as systemic whole-body treatment, including thymic peptides, interferon, interleukins, except for local use to control pleural effusion. 4. Previous chest radiotherapy. 5. A history of allogeneic organ transplantation (except for corneal transplantation) or allogeneic hematopoietic stem cell transplantation. 6. Allergic to the study drug, Sintilimab, or its excipients. 7. A history of human immunodeficiency virus (HIV) infection (i.e., HIV1/2 antibody positive). 8. Untreated active hepatitis B defined as HBsAg positive and HBV-DNA copy number greater than the upper limit of the normal value in the laboratory of the study center. Note: Patients with hepatitis B who meet the following criteria can also be included: 1. HBV viral load \<1000 copies/ml (200IU/ml) before the first dose; the patient should receive anti-HBV treatment throughout chemotherapy in the entire study to avoid viral reactivation. 2. For patients who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), no prophylactic anti-HBV treatment is required, but close monitoring of viral reactivation is needed. 9. Active hepatitis C virus (HCV) infection defined as HCV antibody positive and HCV-RNA levels higher than the detection limit. 10. Having received live vaccines within 30 days prior to the first dose (Cycle 1, Day 1). Note: It is allowed to receive inactivated virus vaccines for seasonal influenza within 30 days prior to the first dose, but attenuated live influenza vaccines administered intranasally are not allowed. 11. Pregnant or lactating women; 12. Any serious or uncontrollable systemic diseases, such as: 1. Significant and symptomatic abnormalities in rhythm, conduction or morphology on resting electrocardiogram, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmia, or atrial fibrillation; 2. Unstable angina, congestive heart failure, or chronic heart failure classified as New York Heart Association (NYHA) class ≥ 2; 3. Any arterial thrombosis, embolism or ischemic events, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, occurring within 6 months prior to enrollment; 4. Poor blood pressure control defined as systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg; 5. A history of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to initial treatment, or current clinical activity of interstitial lung disease; 6. Active pulmonary tuberculosis; 7. Active or uncontrolled infections requiring systemic therapy; 8. Active diverticulitis, abdominal abscess, or gastrointestinal obstruction; 9. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 10. Poorly controlled diabetes (fasting blood glucose (FBG) \> 10mmol/L); 11. Urine protein ≥ ++ on routine urinalysis, with confirmed 24-hour urine protein quantification \> 1.0 g; 12. Psychiatric disorders that are unable to comply with treatment. 13. Any other medical histories, disease evidence, treatment, or laboratory values that may interfere with the test results, hinder the full participation in the study, or other situations that the investigator deems unsuitable for inclusion due to potential risks.
Contact & Investigator
Jianyang Wang, MD
STUDY DIRECTOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Frequently Asked Questions
Who can join the NCT06342167 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Locally Advanced Esophageal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06342167 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06342167 currently recruiting?
Yes, NCT06342167 is actively recruiting participants. Contact the research team at pkucell@163.com for enrollment information.
Where is the NCT06342167 trial being conducted?
This trial is being conducted at Beijing, China, Fujian, China, Handan, China, Anyang, China and 6 additional locations.
Who is sponsoring the NCT06342167 clinical trial?
NCT06342167 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The principal investigator is Jianyang Wang, MD at Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College. The trial plans to enroll 57 participants.