Second-line Surufatinib Combined With Chemotherapy in Advanced CRC

NCT04734249 | Unknown Phase 2

• 1 other identifier: HMPL-012-SPRING-C103(SYLT-020)
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

A phase II, muti-cohort study to assess the efficacy and safety of Surufatinib combined with chemotherapy as a second-line treatment in patients with advanced CRC

Conditions

Advanced Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  CR + PR rate according to the RECIST version 1.1 guidelines.

  up to 12 months

Secondary Outcomes (3)

• Progression Free Survival (PFS)

  up to 12 months

• Overall survival time

  up to 36 months

• Assess the anti-tumor activity:DCR

  up to 12 months

Study Arms (1)

Advanced CRC

EXPERIMENTAL

Patients with Advanced CRC were given Surufatinib Combined With Chemotherapy

Drug: Surufatinib(HMPL-012)

Interventions

Surufatinib(HMPL-012) DRUG

1. Cohort 1:Surufatinib(250mg ,qd,po)+mFOLFOX6/FOLFIRI,14 days for a cycle.The curative effect was evaluated every 4 cycles. Cohort 2:Surufatinib(250mg ,qd,po)+FOLFOXIRI,14 days for a cycle.The curative effect was evaluated every 4 cycles. 2. if the first-line chemotherapy was used FoLFOX ,the second-line is FOLFIRI,or the first-line chemotherapy was used FOLFIRI ,the second-line is FoLFOX. 3. Second-line Surufatinib Combined With Chemotherapy in Advanced CRC.

Also known as: Chemotherapy(mFOLFOX6/FOLFIRI,FOLFOXIRI)

Advanced CRC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures, sampling and analyses.
• Male or female, age18-75 years.
• Pathologically confirmed unresectable locally advanced or advanced metastatic colorectal adenocarcinoma .
• The patient had previously failed standard first-line systemic chemotherapy,Prior adjuvant and neo-adjuvant therapy is permitted (chemotherapy, radiotherapy, investigational agents) if 6 months or more have passed since completion of therapy.
• A WHO performance status equal to 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
• At least 1 lesion that has not previously been irradiated, that has not been chosen for biopsy during the study screening period, and that can be accurately measured at Baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15mm) with computerized tomography (CT) or magnetic resonance imaging (MRI), whichever is suitable for accurately repeated measurements. If only one measurable lesion exists, it is acceptable to be used (as a target lesion) as long as it has not been previously irradiated and baseline tumour assessment scans are done at least 14days afar the screening biopsy is performed.
• Inadequate bone marrow reserve or organ function, as demonstrated by any of the following laboratory values:
• Absolute neutrophil count (ANC) ≥1.5×109/L
• Platelet count ≥100×109 / L
• Hemoglobin≥90 g/L（\<9 g/dL）
• Alanine aminotransferase ≤2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases.
• Aspartate aminotransferase (AST) ≤ 2.5 × ULN if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases.
• Total bilirubin (TBL)≤ 1.5 × ULN if no liver metastases or ≤ 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases.
• Creatinine≤ 1.5 × ULN concurrent with creatinine clearance ≤50 mL/min (measured or calculated by the Cockcroft-Gault equation); confirmation of creatinine clearance is only required when creatinine is ≤1.5 × ULN.
• Females should be using adequate contraceptive measures throughout the study; should not be breastfeeding at the time of screening, during the study and until 3 months after completion of the study; and must have a negative pregnancy test prior to start of dosing if of childbearing potential or must have evidence of non-childbearing potential by fulfilling 1 of the following criteria at Screening:

You may not qualify if:

• Treatment with any of the following:
• Prior treatment with Surufatinib .
• Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug.
• Radiotherapy with a limited field of radiation for palliation within 4 week of the first dose of study drug, with the exception of patients receiving radiation to \> 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.
• Patients with other malignancies, except basal cell carcinoma and carcinoma in situ..
• Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment, with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.
• Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 2 weeks prior to start of study treatment.
• Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension or active bleeding diatheses, which, in the Investigator's opinion, makes it undesirable for the patient to participate in the trial OR which would jeopardize compliance with the protocol such as active infection. Screening for chronic conditions is not required.
• Refractory nausea, vomiting, or chronic gastrointestinal diseases, inability to swallow the study drug, or previous significant bowel resection that would preclude adequate absorption of Surufatinib.
• Any of the following cardiac criteria:
• Mean resting corrected QT interval (QTc) \> 470 ms obtained from 3 electrocardiograms (ECGs), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF).
• Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG (e.g., complete left bundle branch block, third-degree heart block, second-degree heart block, PR interval \> 250 ms).
• Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval.
• Left ventricular ejection fraction (LVEF) ≤ 40%.
• Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active interstitial lung disease.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Officials

• Rongbo Lin

  Fujian Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

Rongbo Lin

CONTACT

13705919382; rongbo_lin@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 2, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2021
• Study Completion: December 1, 2023
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share