Overview

Surufatinib, Toripalimab and Chemotherapy in Second-line MT and MSS CRC

Status:
Recruiting
Trial end date:
2025-01-01
Target enrollment:
0
Participant gender:
All
Summary
To determine the efficacy and safety of surufatinib, toripalimab and chemotherapy in second-line RAS/BRAF mutant and MSS colorectal cancer
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Zhejiang University
Criteria
Inclusion Criteria:

1. Age ≥ 18 years, ≤75 years

2. Histologically confirmed colorectal cancer with distant metastasis.

3. ECOG 0-1

4. Progression on first line therapy

5. RAS/BRAF mutant and microsatellite stable

6. Patients can swallow pills normally

7. Expected overall survival ≥6 months

8. Blood routine: no blood transfusion or blood products usage within 14 days, G-CSF or
other hematopoietic stimulator was not used. WBC counts > 3000/µl,Absolute neutrophil
count (ANC) ≥ 1500 cells/µl,Platelet count ≥ 100,000/µl,Hemoglobin ≥ 9.0 g/dL.

9. AST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN),Serum
bilirubin ≤ 1.5 x ULN,creatinine
10. Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN

11. Patients who have not received immunotherapy

12. Women of childbearing age must be willing to use adequate contraceptives during the
study period of drug treatment;

13. Informed consent has been signed.

Exclusion Criteria:

1. Patients have received ≥2 line systemic therapy;

2. Active bleeding within 3 months; Occurrence of arterial/venous thrombosis within 6
months; Hereditary or acquired bleeding (e.g., clotting dysfunction) or thrombotic
tendencies; Full dose oral or injectable anticoagulants or thrombolytic drugs for
therapeutic purposes are currently being used or have been used recently (10 days
prior to the commencement of study treatment); Surgery (except for biopsy) was
performed within 4 weeks prior to the study or the surgical incision was not fully
healed; Aspirin (> 325 mg/ day) or dipyridamole, ticlopidine, clopidogrel, and
silotazole are currently being used or have recently been used (10 days prior to the
study).

3. Systemic corticosteroids or other systemic immunosuppressive drugs were used within 2
weeks prior to treatment. Immunosuppressive drugs were started or expected to be used
during the trial. Inhaled corticosteroids, physiologic replacement doses of
glucocorticoids are allowed.

4. Certain or suspected brain metastases.

5. The patient has a history of autoimmune disease.

6. Serious uncontrolled systemic diseases, such as severe active infections;

7. A person is known to be infected with the immunodeficiency virus (HIV) or known to be
HIV-positive;

8. Patients have suffered from other malignancies in the past 5 years except cervical
carcinoma in situ or basal cell carcinoma of the skin

9. Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA
>500 IU/mL) or active HCV carriers with HCV RNA can be detected. Remarks: Inactive
hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients
(HBV DNA < 500 IU/mL) may be enrolled

10. Anti-infective therapy was not discontinued 14 days before the study;

11. A prior history of interstitial lung disease, drug-induced interstitial lung disease,
radiation pneumonia, and symptomatic interstitial lung disease or the presence of
active pneumonia on a chest CT scan within 4 weeks prior to the study.

12. Patients have a history of intestinal obstruction within six months. Patients with
incomplete obstruction syndrome of ileus at the time of initial diagnosis may be
enrolled in the study if they have received definitive (surgical) treatment to resolve
the symptoms, as assessed by the investigator.

13. Patients Have high blood pressure that cannot be well controlled by antihypertensive
medication (systolic ≥140 mmHg or diastolic ≥90 mmHg)

14. Urine routine indicated urinary protein ≥++ and confirmed 24-hour urinary protein
>1.0g;

15. Known to be allergic to any study drug;

16. Patients have participated in other drug clinical studies within 4 weeks before
enrollment;

17. Lactating women

18. According to the judgment of the researcher, the patient may have other factors that
may affect the results of the study or cause the study to be terminated, such as
alcohol abuse, drug abuse, other serious diseases (including mental diseases)
requiring combined treatment. Patients have severe laboratory abnormalities, which
will affect the safety of the patient.