Esophagus cancer
Conditions
Interventions
Immunochemoradiotherapy group:Immunochemoradiotherapy
Immunochemotherapy group:Immunochemotherapy
Sponsors
Sichuan Cancer Hospital & Institute
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. In the newly treated patients with oligometastases of advanced esophageal squamous cell carcinoma, the stage was TanyNanyM1 (oligometastases were defined as the number of metastatic lesions =1.5x10^9/L; Hemoglobin (HB)>=9g/dL; Platelet (PLT)>=100x10^9/L; Serum albumin (ALB)>=2.8g/ dL; White blood cell (WBC)>=4.0x10^9/L; (2) Biochemical inspection must meet: Total bilirubin (TBIL)=50mL/min (Cockcroft-Gault formula); blood urea nitrogen (BUN) is within the normal range; thyroid function is normal; (3)Normal thyroid function: Serum thyroxine of T4:65~155nmol/L(5.0~12.0µg/dL; Serum thyroxine of FT4:10.3~31.0pmol/L(0.8~2.3ng/dL); Serum triiodothyronine of T3: 1.8~2.9nmol/L(115~190ng/dL); FT3 serum free triiodothyronine: 2.0-6.6 pmol/L; TSH serum thyrotropin: 0.3~5.0mU/L; 6. Estimated survival time > 6 months; 7. The investigator determined that the patient can be treated with toripalimab; 8. The patient has no autoimmune diseases; 9. Female subjects with fertility should undergo a urine or serum pregnancy test within 72 hours before receiving the first study drug administration, and prove to be negative, and are willing to administer teriprizumab during the trial period to the last time use effective methods of contraception within the next 3 months; for male subjects whose partners are women of childbearing age, effective methods of contraception should be used during the trial and within 3 months after the last administration of toripalimab; 10. The patient voluntarily joins the study and signs the informed consent (ICF), has good compliance and cooperates with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Cancer specific exclusion criteria: (1) Active or untreated CNS metastases (for example, brain or pia mater) as determined by CT or magnetic resonance (MRI) evaluation and previous imaging evaluation during the screening period; (2) The location or number of tumor metastasis is too large, which has exceeded the aforementioned oligometastasis location range; (3) Uncontrolled tumor-related pain; (4) Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently); subjects are allowed to indwell a catheter; (5) Uncontrollable or symptomatic hypercalcemia (>1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium>ULN); (6) Malignant tumors with a history of malignant tumors other than esophageal cancer within 5 years before random assignment, but the risk of metastasis or death is negligible [for example, the expected 5-year overall survival rate is >90%], and malignant tumors that are expected to be cured after treatment Exceptions include properly treated cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer undergoing radical surgery, and ductal carcinoma in situ undergoing radical surgery; (7) Multi-segmental vertebral body, ilium and other bone metastases, which are likely to cause bone metastases in subjects with fractures and at risk of paraplegia, affecting follow-up follow-up; (8) A single liver metastasis > 5 cm or the load of liver metastasis accounts for more than 50% of the entire liver volume; (9) Subjects who are known to have complete obstruction under endoscopy and require interventional treatment or surgical treatment to relieve the obstruction. 2. Subjects who meet any of the following will be excluded from this trial: (1) After stent implantation in the esophagus or trachea; (2) Those who have received surgery, radiotherapy, chemotherapy, targeted drug therapy, programmed cell death protein-1 (PD-1), PD-L1 or programmed cell death protein ligand-2 (PD-L2) drugs Treatment or other tumor immunotherapy; (3) Subjects who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or subjects who have formed a fistula; (4) Subjects with severe malnutrition (PG-SGA>=9) who could not be corrected after 1 to 2 weeks of active nutritional therapy; (5) Those who are known or suspected of being allergic to the components of toripalimab, paclitaxel, carboplatin and Cisplatin; (6) Those who already have or combined with bleeding disorders; (7) Subjects during pregnancy and lactation; (8) Those who have no informed consent due to psychological, family, social and other factors; (9) Subjects with severe heart, lung, liver, kidney dysfunction, hematopoietic system diseases, immune system diseases, and cachexia; (10) Active infection or fever of unknown cause occurred during the screening period and before the first administration > 38.5? (according to the judgment of the investigator, the subject can be included in the group for fever caused by the tumor); (11) Suffering from congenital or acquired immune deficiency (such as HIV infection), active hepatitis B (HBV-DNA >= 10^4 copies/mL) or hepatitis C (hepatitis C antibody positive, and HCV-RNA is higher than the detection limit of the analysis method) ); (12) Subjects are participating in other clinical studies; (13) Live vaccines have been vaccinated within 4 weeks b
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median progression-free survival, mPFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR;Disease control rate, DCR;Duration of Response, DOR;Median overall survival, mOS;1- and 2-year overall survival rates;Patients' health-related quality of life, HRQoL; | — |
Countries
China
Contacts
Public ContactWang Qifeng
Sichuan Cancer Hospital & Institute
Outcome results
None listed