Actively Recruiting
Efficacy and Safety Study of Thymalfasin with Regorafenib and Tislelizumab in Advanced pMMR/MSS Colorectal Cancer Who Failed Standard Care: Multicenter Randomized Controlled Trial
Led by Beijing Friendship Hospital · Updated on 2025-02-17
52
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
B
Beijing Friendship Hospital
Lead Sponsor
P
Peking Union Medical College Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of Thymalfasin combined with targeted immunotherapy drugs Regorafenib and Tislelizumab compared to Regorafenib and Tislelizumab alone in patients with advanced mismatch repair-proficient (pMMR) or microsatellite stable (MSS) colorectal cancer who have not responded to standard treatments. This Phase II randomized controlled study aims to compare progression-free survival between these two treatment approaches. The study will enroll 52 subjects across multiple centers with specific statistical assumptions guiding enrollment and analysis. Participants will be randomly assigned to one of two groups: a triple therapy group receiving Thymalfasin subcutaneously twice weekly along with oral Regorafenib and intravenous Tislelizumab, or a double therapy group receiving only Regorafenib and Tislelizumab. Regorafenib will start at 80 mg orally daily for two weeks followed by a one-week break, with an increase to 120 mg daily if tolerated. Tislelizumab is given by intravenous infusion once every 21 days. Treatment continues until disease progression according to iRECIST criteria or unacceptable side effects occur. During the study, participants will be monitored for disease progression and adverse events with regular assessments including imaging to measure tumor response. The primary outcome is progression-free survival at 48 weeks. Secondary outcomes include 18-week progression-free survival rate, objective response rate, disease control rate, and overall survival up to three years. Safety and tolerability will also be assessed throughout the trial. The total study duration includes enrollment over 9 months and follow-up for up to 15 months.
CONDITIONS
Brief Title
"Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS/pMMR Colorectal Cancer"
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to sign informed consent and comply with study requirements
- Male or female aged 18 to 75 years
- Histologically or cytologically confirmed advanced or metastatic colorectal adenocarcinoma
- Mismatch repair-proficient (pMMR) or microsatellite stable (MSS) status confirmed by testing
- ECOG performance status of 0 or 1
- At least one measurable lesion per iRECIST
- Expected survival of at least 3 months
- Disease progression or intolerance after at least second-line standard systemic therapy
- Normal major organ function and blood test results within 14 days before randomization
- Ability to swallow and absorb oral medication
- Females of childbearing potential must use contraception during and for 6 months after the study
- Males must be sterilized or use contraception during and for 6 months after the study
You will not qualify if you...
- Previous treatment with Regorafenib, PD-1, PD-L1, CTLA-4 inhibitors, or any immunotherapy
- Immunotherapy or immune-affecting treatments within 6 months prior to study drug
- Radiotherapy, major surgery, or study drug within 28 days before first dose
- Any anti-tumor treatment within 3 weeks before first dose
- Symptomatic or untreated central nervous system metastases
- Known allergy or intolerance to study drugs
- Pregnant or breastfeeding females
- History of other malignancies within 5 years (except certain skin cancers)
- Symptomatic congestive heart failure or uncontrolled arrhythmias
- Poorly controlled hypertension despite treatment
- Recent unstable angina or myocardial infarction
- Major thrombotic or bleeding events within 6 months
- Active or suspected autoimmune diseases
- Recent immunosuppressive therapy except low-dose steroids
- Diagnosed immunodeficiency or chronic systemic steroid use above 10 mg prednisone daily
- History of interstitial lung disease
- Active tuberculosis or treatment within 1 year
- Active hepatitis B or C
- Known HIV or syphilis infection
- Active severe infections requiring treatment within 4 weeks
- Unresolved significant toxicity from prior cancer treatments
- Recent gastrointestinal diseases affecting eligibility
- Severe liver cirrhosis or related complications
- Live vaccination within 30 days prior to study start
- History of alcohol or drug abuse
- Other serious medical or psychiatric conditions that could affect study participation or interpretation of results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or intolerable adverse reaction
Participants receive study drugs including Thymalfasin (subcutaneous twice weekly), Regorafenib (oral daily in 2-week on/1-week off cycles), and Tislelizumab (intravenous infusion every 21 days), continuing until disease progression or unacceptable side effects.
Regular visits aligned with drug administration schedules
Trial Site Locations
Total: 1 location
1
Beijing Friendship Hospital, Capital Medical University
Beijing, China, China, 100050
Actively Recruiting
Research Team
Z
Zhigang Bai, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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