Gastrointestinal tumors
Conditions
Interventions
Experimental group:Camrelizumab + Apatinib mesylate
Sponsors
Harbin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18 to 75 years old, regardless of gender; 2. Clinically diagnosed advanced gastrointestinal tumors with measurable tumor lesions (spiral CT or MR scan >= 10 mm, meeting the RECIST 1.1 standard); 3. ECOG PS score: 0-2 points; 4. For patients with liver cancer, Child-Pugh liver function score is A or better B ( 3 months; 6. Clinical assessment cannot tolerate radical surgical resection; 7. Patients who have undergone standard treatment in the past and have failed the previous treatment; 8. Patients who have not previously received the combination therapy of immune checkpoint inhibitors and small molecule anti-angiogenic drugs; 9. The functions of important organs meet the following requirements (excluding the use of any blood components and cell growth factors during the screening period): (1) The absolute count of neutrophils >= 1.5 x 10^9/L; platelets >= 80 x 10^9/L; hemoglobin >= 9 g/dL; (2) Thyroid-stimulating hormone (TSH) <= 1 x ULN (if abnormal, T3 and T4 levels should be examined at the same time, if T3 and T4 levels are normal, they can be included in the group); (3) Bilirubin <= 1.5 x ULN; ALT and AST <= 5 x ULN; (4) Serum creatinine <= 1.5 x ULN; 10. Women of childbearing age must take a negative pregnancy test (Beta HCG) before starting treatment. Women and men of childbearing age (have sex with women of childbearing age) must agree to use contraceptive measures uninterruptedly during treatment and 6 months after the last therapeutic dose is administered; 11. The subject voluntarily joined the study and signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breastfeeding, or have fertility but refuse to take contraceptive measures; 2. Suffer from other malignant tumors within 5 years, except for fully treated cervical carcinoma in situ or skin squamous cell carcinoma, or skin basal cell carcinoma that has been basically controlled; 3. Active bleeding or abnormal coagulation function (PT > 16s, APTT > 43s, INR > 1.5 x ULN), or have bleeding tendency or are receiving thrombolytic therapy; 4. Those who have not effectively controlled, symptomatic brain metastases, or have a history of uncontrollable mental illness, or have severe intellectual or cognitive dysfunction; 5. Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia and severely impaired lung function; 6. Subjects with active, known or suspected autoimmune diseases, hypothyroidism that only needs hormone replacement therapy, skin diseases that do not require systemic treatment can be selected (such as vitiligo, psoriasis, or hair loss); 7. Congestive heart failure, uncontrollable arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months; or other patients who cannot tolerate surgery; 8. Severe active infection that requires intravenous antibiotic treatment during the screening period; 9. Those who are allergic to experimental drugs; 10. Live vaccines have been vaccinated or will be vaccinated within 30 days before the administration of Carrelizumab; 11. Known history of HIV infection; 12. There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction, which will seriously affect the use and absorption of medications); 13. Patients who cannot follow the trial protocol or cannot cooperate with the follow-up; 14. The researcher believes that it is inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS(Progress-free survival); | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR(Objective Response Rate);DCR(Disease Control Rate);OS(Overall Survival);QoL (Quality of life);Safety; | — |
Countries
China
Contacts
Public ContactHan Yu
Harbin Medical University Cancer Hospital
Outcome results
None listed