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Surufatinib + Tislelizumab for Cancer
Study Summary
This trial is testing a new cancer drug, surufatinib, in combination with another drug, tislelizumab. It will evaluate how well the new drug combination works, how safe it is, and what side effects it causes. The trial has two parts: first, a dose-finding phase to see what doses are safe and effective; and second, a dose-expansion phase to learn more about the new drug combination's safety and efficacy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My high blood pressure is not controlled by medication.I have been treated with surufatinib before.I have a serious heart condition.You have lesions that can be measured according to specific guidelines.I am 18 years old or older.I haven't had a stroke or blood clot in the last year.I agree to use effective birth control during the study.I haven't had serious bleeding or life-threatening blood clots in the past 6 months.My stomach cancer has worsened after two treatments and tests positive for PD-L1.My cancer has worsened in the last 3 months and I've either tried or refused standard treatment.My cancer is a low or intermediate grade NET from the chest or gut area and has worsened in the last 6 months despite treatment.I have an autoimmune disease, but it's either controlled or not expected to worsen.You have identifiable growths that can be assessed using specific guidelines for evaluating tumors.I am fully active or restricted in physically strenuous activity but can do light work.My thyroid cancer cannot be removed by surgery and I've had one treatment if it has a BRAF mutation.I haven't had surgery or radiotherapy for brain metastases, and I haven't taken steroids in the last 4 weeks.I do not have any serious infections, including HIV.My cancer is advanced or has spread and was confirmed by a lab test.My side effects from previous cancer treatments are mild or gone.I have had a deep vein clot in the past 6 months.My colon or rectum cancer is stable but has not responded to at least 3 treatments.I have CRC, NETs, or STS and have been treated with specific immune therapies before.I am not pregnant or breastfeeding.My small cell lung cancer worsened after first-line chemotherapy.My cancer is advanced or has spread, confirmed by lab tests.
- Group 1: Surufatinib and tislelizumab (dose escalation_Part 1)
- Group 2: Surufatinib and tislelizumab (indication specific_Part 2)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this the inaugural clinical experiment of its genre?
"Presently, there are 126 active trials examining the effects of Surufatinib and Tislelizumab _ Part 2 being conducted in 429 cities across 46 nations. This research initiative was first initiated by Hutchison Medipharma Limited back in 2015 when 195 volunteers were enrolled for Phase 3 drug approval stage. Since then, 24 studies have been concluded."
What objectives is this research endeavor attempting to fulfill?
"This investigation, projected to run for up to two years, has the primary goal of evaluating Dose Limiting Toxicity. Secondary objectives include Overall Survival from enrollment date to death date and Disease Control Rate (DCR) which accounts for complete response, partial response or stable disease. Lastly, Duration of Response (DoR) records how long it takes before relapse or advancement is noticed by researchers."
What other research has been conducted regarding the combination of Surufatinib and Tislelizumab Part 2?
"Currently, 126 clinical trials are investigating Surufatinib and Tislelizumab _ Part 2. Notably, 21 of those experiments have reached Phase 3. However, while the majority of these studies take place in Nanning, Guangxi there is a total of 2407 sites conducting research for this medication."
Is the recruitment process for this trial ongoing?
"Affirmative. Clinicaltrials.gov data attests to this medical trial's current recruitment status, with its initial posting having been on March 5th 2021 and being updated as recently as October 3rd 2022. 135 participants are needed from 18 distinct locations."
Are there plentiful medical facilities conducting this clinical research in the city?
"This study is currently being conducted at The University of Texas MD Anderson Cancer Center in Houston, Mary Crowley Cancer Research in Dallas, and Rocky Mountain Cancer Centers Midtown in Denver. Additionally, it can be found across 18 other medical centres."
How many participants have been recruited for this clinical research endeavor?
"The study sponsor, BeiGene, is looking for 135 patients to meet the inclusion criteria and participate in the trial. The research will be conducted out of two major hubs: The University of Texas MD Anderson Cancer Center in Houston, TX and Mary Crowley Cancer Research in Dallas, CO."
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