Apatinib Monotherapy Versus Apatinib Combined With Camrelizumab for Third-line Treatment of Metastatic Gastric Cancer

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This open, single-center, randomized phase II study was to evaluate the clinical benefit of apatinib plus camrelizumab which is an anti-Programmed cell death-1 (PD-1) monoclonal antibody, versus apatinib in patients with metastatic gastric cancer refractory to two or more lines of treatment, fully evaluating the efficacy and safety of the combined regimen.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Apatinib

Criteria

Inclusion Criteria:

1. Age ≥18;

2. Locally advanced or recurrent/metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by histopathological examination;

3. Standard treatment failure of no less than two lines of systematic treatment (treatment failure is defined as intolerance of toxic and side effects, disease progression during treatment or recurrence after treatment);

4. With one or more measurable lesions, the longest diameter measured by spiral CT scan should be at least 10 mm, and the longest diameter measured by conventional CT scan should be at least 20 mm (RECIST standard, version 1.1);

5. ECOG score was 0-2;

6. Life expectancy ≥12 weeks;

7. The patient has recovered from damage caused by other anti-tumor therapy, received cytotoxic drugs, radiotherapy or surgery for ≥4 weeks, and the wound has completely healed;

8. Bone marrow capacity and liver and kidney function were sufficiently reserved 7 days before screening: absolute neutrophil (ANC) count ≥1.5x109 /L; Hemoglobin ≥ 8.0g/ dL; Platelet count ≥80 x109 /L; Total bilirubin < 1.5 times upper normal limit (ULN); ALT and AST< 2.5x ULN (with liver metastasis <5x ULN); Serum creatinine ≤1 x ULN, the clearance rate of endogenous creatinine >50ml/min;

9. Women of childbearing age should take effective contraceptive measures;

10. Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up.

Exclusion Criteria:

1. A history of other malignant tumors within 5 years, except cured cervical carcinoma in situ or basal cell carcinoma of the skin;

2. Patients with hypertension that could not be controlled by antihypertensive medication (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg), coronary heart disease of grade I or above, arrhythmia of grade I or above (including prolonged QTc interval > 450ms in males and > 470 ms in females) and cardiac dysfunction of grade I or above;

3. Symptomatic brain or meningeal metastases (unless the patient was treated for >6 months, imaging results were negative within 4 weeks prior to study entry, and tumor-related clinical symptoms were stable at study entry);

4. with a history of uncontrolled epileptic seizures, central nervous system dysfunction, or mental disorders;

5. Uncontrolled pleural or abdominal effusion;

6. Undergoing kidney dialysis;

7. severe or uncontrolled infection;

8. pregnant or lactating women who are fertile but have not taken adequate contraceptive measures;

9. Multiple factors affecting oral medication (inability to swallow, chronic diarrhea and intestinal obstruction);

10. Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg< 2G /L), bleeding tendency or receiving thrombolytic or anticoagulant treatment;

11. patients with gastrointestinal bleeding risk should not be enrolled, including the following conditions :(1) active peptic ulcer lesions and fecal occult blood (++); (2) patients with history of black stools and hematemesis within 3 months;

12. Prior exposure to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, CTLA-4 antibody therapy, or any other antibody or drug that specifically targets T-cell costimulation or immune checkpoint pathways.

13. Participated in clinical trials of other drugs within four weeks

14. Urine routine examination indicated urine protein > 2+

15. Received systemic systemic therapy with anti-tumor indications of Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration;

16. Use of immunosuppressive agents within 4 weeks prior to the first dose of study therapy, excluding nasal, inhaled, or other topical or physiological doses of systemic glucocorticoids (i.e., no more than 10 mg/ d of prednisone or equivalent doses of other glucocorticoids), or hormone use for the prevention of contrast agent allergy.

17. Residual liver volume is less than 50% of the total liver volume.