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Second-line Surufatinib Combined With Chemotherapy in Advanced CRC | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Second-line Surufatinib Combined With Chemotherapy in Advanced CRC

A Multi-cohort and Controlled Study to Evaluate the Efficacy and Safety of Surufatinib Combined With Chemotherapy as Second-line Treatment of Metastatic Colorectal Cancer

NCT04734249•Fujian Cancer Hospital

View on ClinicalTrials.gov

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

Detailed Description

This study adopt Simon's two-stage minimax designs method based on the primary endpoint of objective response rates. In each arm, 15 patients were planned for the first stage. If two or more responses were observed, an additional 13 patients were to be accrued for a total of 28 patients. If 7 or more of the 28 patients in an arm achieved an objective response, then that arm was designated worthy of additional investigation. Surufatinib will be orally administered within 1 hour after breakfast once a day (QD) , Cohort 1 :Surufatinib+mFOLFOX6/FOLFIRI,Cohort 2 :Surufatinib+FOLFOXIRI for every 14-day treatment cycle until disease progression, death, intolerable toxicity or other protocol specified end-of-treatment criteria is met (which comes first).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Provision of informed consent prior to any study specific procedures, sampling and analyses.
•2. Male or female, age18-75 years.
•3. Pathologically confirmed unresectable locally advanced or advanced metastatic colorectal adenocarcinoma .
•4. 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.
•5. A WHO performance status equal to 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
•6. 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.
•7. Inadequate bone marrow reserve or organ function, as demonstrated by any of the following laboratory values:
•1. Absolute neutrophil count (ANC) ≥1.5×109/L
•2. Platelet count ≥100×109 / L
•3. Hemoglobin≥90 g/L（\<9 g/dL）
+8 more criteria

Exclusion Criteria

•1. Treatment with any of the following:
•1. Prior treatment with Surufatinib .
•2. Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study drug.
•3. 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.
•2. Patients with other malignancies, except basal cell carcinoma and carcinoma in situ..
•3. 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.
•4. Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 2 weeks prior to start of study treatment.
•5. 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.
•6. 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.
•7. Any of the following cardiac criteria:
+11 more criteria

Key Dates

Start Date

March 1, 2021

Primary Completion Date

March 1, 2021

Completion Date

December 1, 2023

Last Updated

February 2, 2021

Enrollment

ESTIMATED participants

Conditions

Advanced Colorectal Cancer

Interventions

Surufatinib(HMPL-012)

DRUG

Contacts

Rongbo Lin

CONTACT

13705919382 rongbo_lin@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Second-line Surufatinib Combined With Chemotherapy in Advanced CRC

Inclusion Criteria

Exclusion Criteria

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