synchronous hypopharyngeal cancer (HPC) and esophageal cancer (EC)
Conditions
Interventions
Test group:toripalimab in combination with induction chemotherapy and concurrent chemoradiation or combined with radical chemoradiotherapy
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed unresectable, treatment-naive, synchronous hypo-pharyngeal cancer and esophageal cancer, suitable for radical radiotherapy to at least one lesion. 2. Inoperable (whether for medical reasons or reasons of patient choice); 3. Age at diagnosis being 18-75 years; 4. PS score 0-1; 5. At least 1 measurable lesion for at least one lesion according to RECIST v1.1; 6. The function of important organs meets the following requirements(No blood components or cell growth factors are allowed 2 weeks prior to starting study treatment); 7. a.white blood cell count (WBC) >= 4.0×10^9/L, absolute neutrophil count (ANC) >= 1.5×10^9/L; b. platelets >= 100×10^9/L; c. hemoglobin >= 9g/dL; d. serum albumin >= 2.8g/dL; 8. e. total bilirubin 60 mL/min; g. normal thyroid function; Blood urea nitrogen (BUN) within normal limits; 9. Estimated life expectancy >6 months; 10. The investigators determined that the patient could be treated with karelizumab; 11. The patient has no autologous autoimmune disease; 12. Patient residuals after hypopharyngeal or esophageal ESD; 13. The patient has not received prior systemic antitumor therapy; 14. Female subjects of childbearing potential shall undergo a urine or serum pregnancy test within 72 hours prior to receiving the first dose of study drug and prove negative and be willing to use an effective method of contraception for the duration of the trial up to 3 months after the final administration of carylizumab; in the case of male subjects whose partner is a woman of childbearing potential, they shall use an Effective method of contraception; 15. Ability to understand the study and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. metastases as determined by CT or magnetic resonance (MRI) evaluation and previous imaging evaluation during the screening period; 2. Uncontrolled tumor-related pain; 3. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently); subjects are allowed to indwell a catheter; 4. Uncontrollable or symptomatic hypercalcemia (>1.5 mmol/L ionized calcium or calcium>12 mg/dL or corrected serum calcium>ULN); 5. Malignant tumors with a history of malignant tumors other than hypopharyngeal or 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; 6. subjects who are known to have complete obstruction under endoscopy and require interventional treatment or surgical treatment to relieve the obstruction; 7. Patients with residual lesions after surgical resection. 8. After stent implantation in the esophagus or trachea. 9. 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. 10 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. 11. Severe malnutrition (PG-SGA>= 9 points). and whose nutritional status cannot be corrected after 1 to 2 weeks of active nutritional therapy. 12. Those who are known or suspected of being allergic to the components of Camrelizumab, paclitaxel/albumin, paclitaxel, and carboplatin. 13. Those who already have or combined with bleeding disorders. 14. subjects during pregnancy and lactation. 15. Those who have no informed consent due to psychological, family, social and other factors. 16. subjects with severe heart, lung, liver, kidney dysfunction, hematopoietic system diseases, immune system diseases, and cachexia. 17. 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). 18. 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) ). 19. Subjects are participating in other clinical studies. 20. Live vaccines have been vaccinated within 4 weeks before the first use of the study drug. Inactivated virus vaccines for seasonal influenza and injections are allowed, but live attenuated influenza vaccines for nasal use are not allowed. 21. Major surgery (craniotomy, thoracotomy, or laparotomy) was received within 4 weeks before the first dose of study treatment, or major surgery is expected during the study treatment period. 22. According to the judgment of the investigator, the subject has other factors that may cause him to be forced to terminate the study, such as suffering from other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mPFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 year or 2 year OS;disease control rate (DCR);Safety and tolerability;objective response rate (ORR);Duration of Response (DOR); | — |
Countries
China
Contacts
Public ContactQifeng Wang
Sichuan Cancer Hospital
Outcome results
None listed