Actively Recruiting
"Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS/pMMR Colorectal Cancer"
Led by Beijing Friendship Hospital · Updated on 2025-02-17
52
Participants Needed
1
Research Sites
150 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
This is a multicenter, open-label, prospective, randomized controlled Phase II clinical study. All eligible subjects will be randomly assigned in a 1:1 ratio to either the triple therapy group or the double therapy group. Triple therapy group: Subjects will receive Thymalfasin in combination with Regorafenib and Tislelizumab until iCPD is achieved per iRECIST (progressive disease (PD) per iRECIST), or until an intolerable toxicity occurs; Double therapy group: Subjects will receive Regorafenib and Tislelizumab until iCPD is achieved per iRECIST (PD per iRECIST), or until an intolerable toxicity occurs.
CONDITIONS
Official 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
- Confirmed advanced or metastatic colorectal adenocarcinoma
- Mismatch repair proficient (pMMR) or microsatellite stable (MSS) status
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- At least one measurable lesion per iRECIST criteria
- Expected survival of 3 months or more
- Disease progression or intolerance after at least second-line standard systemic therapy
- Normal hematology and major organ function within 14 days prior to randomization, including WBCs ≥ 2.0×10⁹/L, neutrophils ≥ 1.5×10⁹/L, hemoglobin ≥ 90 g/L, platelets ≥ 100×10⁹/L
- Liver function within specified limits depending on liver metastases status
- Serum albumin ≥ 30 g/L
- Serum creatinine ≤ 1.5 times upper limit of normal and creatinine clearance > 40 mL/min
- Urine protein less than 2+; if 2+ or more, 24-hour urine protein must be less than 1 g
- Prothrombin time and related coagulation tests ≤ 1.5 times upper limit of normal
- Ability to swallow and absorb oral medication
- Females of childbearing potential must use contraception during study and for 6 months after last dose
- Males must be surgically sterilized or use contraception during study and for 6 months after last dose
You will not qualify if you...
- Previous treatment with Regorafenib, PD-1, PD-L1, CTLA-4 inhibitors, or any immunotherapy
- Use of immunomodulating drugs or therapies affecting immunity within 6 months prior to study drug
- Treatment with study drugs, radiotherapy, or major surgery within 28 days before study drug
- Anti-tumor treatment within 3 weeks before study drug
- Symptomatic central nervous system metastases or requiring CNS-directed therapy except stable treated cases
- Known allergy or intolerance to study drugs or components
- Pregnant or lactating women
- Other malignancies within past 5 years except certain skin cancers or cured tumors
- Symptomatic congestive heart failure (NYHA Class II-IV), uncontrolled arrhythmias
- Poorly controlled hypertension (systolic ≥ 150 mmHg or diastolic ≥ 100 mmHg)
- Unstable angina, recent myocardial infarction within 6 months
- Major thrombotic or bleeding events within 6 months or requiring lifelong anticoagulation
- Active or suspected autoimmune diseases
- Immunosuppressive therapy within 4 weeks before study drug, except specific low-dose steroids
- Diagnosed immunodeficiency or chronic systemic steroid use above 10 mg prednisone equivalent
- History of interstitial lung disease
- Active tuberculosis or treatment within 1 year prior to study drug
- Acute or chronic active hepatitis B or C
- Known HIV or syphilis infection
- Severe infections requiring systemic treatment within 4 weeks before study drug
- Unresolved clinical toxicity Grade 2 or higher from prior anti-tumor treatment
- Recent serious gastrointestinal conditions within 6 months
- Severe liver cirrhosis or related conditions
- Live vaccine within 30 days prior to study drug
- History of alcohol or drug abuse
- Other diseases or conditions that may interfere with study or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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