Esophageal cancer.
Conditions
Interventions
Experimental Group:Aipalolitovo Relimab combined with Anlotinib and low-dose radiotherapy
Sponsors
Anhui Provincial Cancer Hospital.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Esophageal squamous cell carcinoma confirmed by histology or cytology; 2. Unresectable locally advanced or recurrent/metastatic esophageal cancer; 3. Age: 18-75 years old, gender not limited; 4. ECOG score 0 to 2; 5. Previously received PD-1/PD-L1 inhibitor combined chemotherapy or sequential therapy as the first-line treatment for advanced metastatic esophageal cancer and experienced disease progression during or after the treatment; 6. Previously received comprehensive treatment (including neoadjuvant, adjuvant/consolidation treatment) mainly involving PD-1/PD-L1 for radical treatment purposes, such as surgery or radiotherapy, and progression occurred during adjuvant/consolidation treatment with PD-1/PD-L1 inhibitors; 7. According to the RECIST 1.1 standard, at least one measurable lesion exists; 8. No serious contraindications for radiotherapy (such as severe pulmonary insufficiency (FEV1 =50% of the predicted value, DLCO=40% of the predicted value; 10. Laboratory tests meet the following requirements: (1) Blood routine: HGB>=90g/L; WBC>=4.0×10^9/L; NEUT>=2.0×10^9/L; PLT >=100×10^9/L; (2) Blood biochemistry: TBIL<=1.5×ULN; ALT and AST<=5×ULN; BUN and Cr are less than or equal to 1.5×ULN, and the creatinine clearance rate is greater than or equal to 50 mL/min. (3) The international normalized ratio (INR) is less than or equal to 2.0, or the prothrombin time (PT) exceeds the normal control range by less than or equal to 6 seconds. 11. The pregnancy test of the patient of childbearing age is negative, and the patient voluntarily takes effective and reliable contraceptive measures during the test period.
Exclusion criteria
Exclusion criteria: Have participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment; 2. Any of the following conditions can interfere with oral medication: inability to swallow, chronic diarrhea and intestinal obstruction; 3. Previously received treatment with PD1/CTLA4 bispecific antibodies; 4. Those who have suffered grade 3 or above radiation damage (such as radiation pneumonitis, esophagitis) after previous radiotherapy and have not recovered; 5. Inability to cooperate with radiotherapy for positioning or treatment (such as severe consciousness disorders, poor range of motion and inability to maintain a fixed position); 6. There is uncontrollable pleural effusion and pericardial effusion; 7. The tumor invades major blood vessels (such as the aorta) and is accompanied by ulcers; 8. At the same time, receive any other systemic anti-tumor treatment (except local treatment); 9. Those who have a history of allergy to the drug components of this plan; 10. Subjects with active infectious diseases; 11. If the patient has hepatitis B virus (HBV) infection: and has received at least one week of anti-HBV treatment before enrollment and is willing to receive antiviral treatment throughout the study period; HCV ribonucleic acid (RNA) positive patients must receive antiviral treatment in accordance with the treatment guidelines and have liver function within CTCAE grade 1 elevation. 12. Significant clinically significant bleeding symptoms or a clear bleeding tendency occurred within 3 months before enrollment, such as gastrointestinal bleeding or hemorrhagic gastric ulcers; 13. Patients who, based on the researcher's judgment, may increase the risks related to the research or may interfere with the interpretation of the research results, etc., are considered unsuitable for enrollment by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Relief (TTR).;Duration of Response (DOR).;Progression-free survival;Disease Control Rate;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactZang Chunbao
Anhui Provincial Cancer Hospital
Outcome results
None listed