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

NCT04653480 | Unknown Phase 2

• 1 other identifier: APHRODITE
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the efficacy and safety of surufatinib, toripalimab and chemotherapy in second-line RAS/BRAF mutant and MSS colorectal cancer

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  the proportion of patients in a trial whose tumor is destroyed or significantly reduced by a drug. ORR is generally defined as the sum of complete responses (CRs) - patients with no detectable evidence of a tumor over a specified time period - and partial responses (PRs) - patients with a decrease in tumor size over a specified time period.

  2 months

Secondary Outcomes (2)

• Overall Survival

  2 years

• Progression Free Survival

  6 months

Study Arms (1)

Surufatinib, Toripalimab and Chemotherapy

EXPERIMENTAL

Second line CRC patients received surufatinib 250mg po qd , toripalimab 3mg/kg ivgtt q2w and chemotherapy according to the first line treatment, until disease progression or intolerable toxicity

Drug: Surufatinib; Drug: Toripalimab; Drug: chemotherapy

Interventions

Surufatinib DRUG

250mg per oral, once daily

Surufatinib, Toripalimab and Chemotherapy

Toripalimab DRUG

3mg/kg IV, once every 2 weeks

Surufatinib, Toripalimab and Chemotherapy

chemotherapy DRUG

oxaliplatin or irinotecan based regimens, according to the first line treatment

Surufatinib, Toripalimab and Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years, ≤75 years
• Histologically confirmed colorectal cancer with distant metastasis.
• ECOG 0-1
• Progression on first line therapy
• RAS/BRAF mutant and microsatellite stable
• Patients can swallow pills normally
• Expected overall survival ≥6 months
• 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.
• AST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN)，Serum bilirubin ≤ 1.5 x ULN，creatinine\<ULN
• Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN
• Patients who have not received immunotherapy
• Women of childbearing age must be willing to use adequate contraceptives during the study period of drug treatment;
• Informed consent has been signed.

You may not qualify if:

• Patients have received ≥2 line systemic therapy;
• 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).
• 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.
• Certain or suspected brain metastases.
• The patient has a history of autoimmune disease.
• Serious uncontrolled systemic diseases, such as severe active infections;
• A person is known to be infected with the immunodeficiency virus (HIV) or known to be HIV-positive;
• Patients have suffered from other malignancies in the past 5 years except cervical carcinoma in situ or basal cell carcinoma of the skin
• 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
• Anti-infective therapy was not discontinued 14 days before the study;
• 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.
• 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.
• Patients Have high blood pressure that cannot be well controlled by antihypertensive medication (systolic ≥140 mmHg or diastolic ≥90 mmHg)
• Urine routine indicated urinary protein ≥++ and confirmed 24-hour urinary protein \>1.0g;
• Known to be allergic to any study drug;

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

First affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

surufatinib; toripalimab; Drug Therapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Weijia Fang, MD.

CONTACT

+86-571-87235147; weijiafang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Medical Oncology

Study Record Dates

• First Submitted: November 28, 2020
• First Posted: December 4, 2020
• Study Start: February 1, 2021
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)