Clinical trial · Observational
Neoadjuvant Immunotherapy (PD-1 / PD-L1) Combined With Chemotherapy for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma: a Single Center, Prospective, Open, One Arm Exploratory Clinical Study
NCT05028231CI-TRIAL-00053610NICCEunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To purpose of this study is to access the safety and efficacy of neoadjuvant Immunotherapy (PD-1 / PD-L1) combined with chemotherapy for locally advanced thoracic esophageal squamous cellcarcinoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neoadjuvant Therapies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant Immunotherapy (PD-1 / PD-L1) Combined With Chemotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Neoadjuvant Immunotherapy (PD-1 / PD-L1) Combined With Chemotherapy
- interventionNames
- Procedure: Neoadjuvant Immunotherapy (PD-1 / PD-L1) Combined With Chemotherapy
Primary outcomes (1)
- measure
- Pathologic Complete Response
- timeFrame
- 2-5 years
- description
- According to the detection of pathological specimens after operation, no malignant tumor cells were detected, so the patient achieved complete pathological remission.
Secondary outcomes (5)
- measure
- Disease-free Survival
- timeFrame
- 2-5 years
- description
- The patient achieved CR (complete remission) and still had no probability of recurrence after treatment in 2-years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-70 Years old, * The clinical stage of esophageal cancer confirmed by pathology was cT(1-3)N(1-3)M0 * No previous chemoradiotherapy * ECOG PS: 0-1 points * The functions of important organs meet the following requirements (excluding the use of any blood components and cell growth factors during the screening period):Absolute neutrophil count ≥ 1.5 × 109/L; Platelet ≥ 90 × 109/L; Hemoglobin ≥ 9g / dl; Serum albumin ≥ 3G / dl; Thyroid stimulating hormone (TSH) ≤ ULN (if abnormal, the levels of T3 and T4 should be investigated at the same time. If the levels of T3 and T4 are normal, they can be included in the group); Bilirubin ≤ ULN; ALT and AST ≤ 1.5 times ULN; AKP ≤ 2.5 times ULN; Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60ml / min. * Women of childbearing age must have taken reliable contraceptive measures or conducted pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate contraceptive methods during the test and 8 weeks after the last administration of test drugs. For men, they must agree to use appropriate methods of contraception or surgical sterilization during the trial and 8 weeks after the last administration of the trial drug. * The patients voluntarily joined the study and signed the informed consent form. They had good compliance and cooperated with the follow-up. Exclusion Criteria: * Any active autoimmune disease or history of autoimmunity (as follows, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism and hypothyroidism; Subjects with vitiligo or asthma in childhood have been completely relieved and do not need any intervention after adulthood can be included; Asthma in which subjects need bronchodilators for medical intervention cannot be included). * Those who have used other drugs in clinical trials within 4 weeks before the first medication. * Severe allergic reaction to monoclonal antibody. * The number of neutrophils in peripheral blood was less than 1500 / mm3. * There are cardiac clinical symptoms or diseases that are not well controlled. * Previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy. * The subjects were innate or acquired immunodeficiency (such as HIV), or active hepatitis (hepatitis B reference: HBsAg) positive, HBVDNA \> 2000IU/ml or copy number \> 104/ml; Hepatitis C reference: HCV antibody positive. * According to the judgment of the researcher, the subject has other factors that may lead to the forced midway termination of this study, such as other serious diseases (including mental diseases) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subject, or the collection of data and samples. * The researchers judged the patients with high risk of esophageal perforation or no potential possibility of surgery through endoscopic ultrasonography or imaging.
References
Publications (15)
- BACKGROUNDPennathur A, Gibson MK, Jobe BA, Luketich JD. Oesophageal carcinoma. Lancet. 2013 Feb 2;381(9864):400-12. doi: 10.1016/S0140-6736(12)60643-6. PMID 23374478
- BACKGROUNDChen MF, Chen PT, Chen WC, Lu MS, Lin PY, Lee KD. The role of PD-L1 in the radiation response and prognosis for esophageal squamous cell carcinoma related to IL-6 and T-cell immunosuppression. Oncotarget. 2016 Feb 16;7(7):7913-24. doi: 10.18632/oncotarget.6861. PMID 26761210
- BACKGROUNDChen K, Cheng G, Zhang F, Zhang N, Li D, Jin J, Wu J, Ying L, Mao W, Su D. Prognostic significance of programmed death-1 and programmed death-ligand 1 expression in patients with esophageal squamous cell carcinoma. Oncotarget. 2016 May 24;7(21):30772-80. doi: 10.18632/oncotarget.8956. PMID 27120796
- RESULTSjoquist KM, Burmeister BH, Smithers BM, Zalcberg JR, Simes RJ, Barbour A, Gebski V; Australasian Gastro-Intestinal Trials Group. Survival after neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal carcinoma: an updated meta-analysis. Lancet Oncol. 2011 Jul;12(7):681-92. doi: 10.1016/S1470-2045(11)70142-5. Epub 2011 Jun 16. PMID 21684205
- RESULTApinop C, Puttisak P, Preecha N. A prospective study of combined therapy in esophageal cancer. Hepatogastroenterology. 1994 Aug;41(4):391-3. PMID 7959579
- RESULTWalsh TN, Noonan N, Hollywood D, Kelly A, Keeling N, Hennessy TP. A comparison of multimodal therapy and surgery for esophageal adenocarcinoma. N Engl J Med. 1996 Aug 15;335(7):462-7. doi: 10.1056/NEJM199608153350702. PMID 8672151
- RESULTUrba SG, Orringer MB, Turrisi A, Iannettoni M, Forastiere A, Strawderman M. Randomized trial of preoperative chemoradiation versus surgery alone in patients with locoregional esophageal carcinoma. J Clin Oncol. 2001 Jan 15;19(2):305-13. doi: 10.1200/JCO.2001.19.2.305.