Esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group:Camrelizumab plus Rivoceranib
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-75 years, male or female. 2. Patients with histologically confirmed advanced esophageal squamous cell carcinoma (clinical stage lV). 3. Completed 4-6 cycles of prior therapy with camrelizumab combined with taxane and platinumbased regimens, with the last assessment showing CR, PR, or SD (RECIST V1.1). 4. Enrollment must occur within 6 weeks after the last dose of induction therapy 5. Toxicities from prior treatment have recovered to s Grade 1 or to baseline levels, except forclinically non-significant and/or stable adverse events managed with supportive care that are notexpected to interfere with the study treatment, such as alopecia (= 1.5 x 10^9/L; Platelet count (PLT) = 75 x 10^9/L; White blood cell count (WBC) = 3.0 x 10^9/L Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2+, a 24-hoururine collection must demonstrate 24-hour urine protein < 1 g. Coagulation function:Activated partial thromboplastin time (APTT), international normalized ratio (lNR), andprothrombin time (PT) <= 1.5 x ULN. 10. For women of childbearing potential, a negative pregnancy test (serum or urine) within 14 daysprior to enrollment is required. Patients must be willing to use effective contraception during thestudy period and for 3 months after the last dose of the study drug. For men, patients must besurgically sterile or agree to use effective contraception during the study period and for 3months after the last dose of the study drug. 11. Patients voluntarily participate and provide written informed consent, are expected to becompliant, and can cooperate with the study per protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with any T-cell co-stimulation or immune checkpoint therapy, including but notlimited to cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PDL1/2 inhibitors, CD137 agonists, or other T-cell-targeting agents. 2.Prior treatment with apatinib. 3. Use of anti-tumor vaccines or other immunostimulatory anti-tumor agents (e.g., interferoninterleukin, thymosin, immune cell therapy) within 1 month prior to the first dose of studytreatment. 4. Use of Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indicationswithin 2 weeks prior to the first dose of study treatment. 5. Systemic treatment with corticosteroids (prednisone >10 mg/day or equivalent) or otherimmunosuppressive agents within 2 weeks prior to the first dose of study treatment. Exceptionsinclude: Corticosteroids for physiologic replacement (prednisone =10 mg/day or equivalent); Topical, ocular, intra-articular, intranasal, or inhaled corticosteroids with minimal systemicabsorption; Short-term use of corticosteroids for hypersensitivity reaction prophylaxis (e.g.premedication for CT scan). 6. History of other malignancies within s5 years prior to enrollment, except for adequately treatedcarcinoma in situ of the cervix, basal cell or squamous cell skin cancer, localized prostate cancertreated with radical surgery, or ductal carcinoma in situ treated with radical surgery. 7. Significant bleeding tendency or coagulopathy, or ongoing thrombolytic therapy. Use of non-steroidal anti-inflammatory drugs (e.g., indomethacin, ibuprofen, naproxen), antiplatelet agents(e.g., clopidogrel, ticlopidine, dipyridamole, cilostazol), or anticoagulants (e.g., warfarin, lowmolecular weight heparin) within 10 days prior to the first dose of study treatment or ongoingrequirement for these medications. 8. inability to swallow oral medications, malabsorption syndrome, or any gastrointestinal condition that may affect the absorption of apatinib. 9. Congenital or acquired immunodeficiency, such as HiV infection, active hepatitis B (HBV DNA >=500 lU/mL), hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of detection)or co-infection with HBv and HCV. 10. Uncontrolled hypertension (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90mmHa desoite cotimal medical management). 11. Myocardial ischemia or myocardial infarction of grade ll or higher, poorly controlled arrhythmias(including QTc interval z450 ms for males or >=470 ms for females). Grade lll-lV cardiacinsufficiency per NYHA criteria, or left ventricular ejection fraction (LVEF) 38.5*C during screening or prior to the first dose. 13. Major surgery, open biopsy, or significant traumatic injury within 28 days prior to enrollment. 14. History of arterial/'venous thrombotic events within 6 months prior to enrollment. 15. $ignificant risk of hemoptysis, bleeding, or perforation as assessed by the investigator. 16. History of allogeneic organ transplantation or allogeneic hematopoi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective Response Rate;Disease Control Rate;Duration of Response;Safty; | — |
Countries
China
Contacts
Public ContactNa Song
The First Hospital of China Medical University
Outcome results
None listed