rSIFN-co in Combination With Total Neo-adjuvant Therapy in Subjects With Mid-low Locally Advanced… (NCT07662278) | Clinical Trial Compass
Not Yet RecruitingPhase 2
rSIFN-co in Combination With Total Neo-adjuvant Therapy in Subjects With Mid-low Locally Advanced Rectal Cancer
90 participantsStarted 2027-01
Plain-language summary
This is a multi-center, randomized, phase II study, aimed to evaluate the efficacy of investigational product at a dose of 1800 µg/day when given in combination with TNT. There will be two arms included in this study: Arm A (TNT regimen
\+ 1800 µg/day of rSIFN-co treatment) and Arm B (TNT regimen only). Subjects will be randomly assigned to any of the two arms in a 2:1 ratio to receive TNT regimen concurrently with rSIFN-co treatment twice a week or TNT regimen only. The efficacy of rSIFN-co when given in combination with Total Neo-adjuvant Therapy (TNT) will be measured by complete response. Where, complete response is defined as subjects with pathological complete response (pCR) or clinical complete response (cCR).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
.Subjects with ECOG Performance Status 0-2 (Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours). \[As per Appendix A\] 5.Subjects with life expectancy of at least 6 months 6.Subjects willing and able to comply with all study requirements, including study treatment, timing and/or nature of required assessments.
.Subjects with normal organ functions prior to enrollment in study:
0.Female subjects of childbearing potential agrees to use a medically acceptable method of contraception throughout the study and for at least 6 months after receiving the final dose.
. Intrauterine device (IUD) or Intrauterine system (IUS)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the complete response rate at the end of treatment period
Timeframe: at the end of treatment period (approximately at week 25)
Trial details
NCT IDNCT07662278
SponsorSichuan Huiyang Life Science and Technology Corporation
. Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent)
. Male sterilization (at least 06 months prior to the screening, should be the sole male partner for that subject)
Exclusion criteria
.Subjects who have received treatment with interferon and interferon-like therapy within 30 days prior to screening.
.Subjects who had present or prior malignancy other than study indication (except cured basal or squamous cell carcinoma, cervical carcinoma).
.Subjects who have received radiotherapy prior to screening or had a history of radiotherapy around the pelvic area.
.Subjects with known or confirmed severe gastrointestinal inflammation, ileus, or chronic diarrhea (\>3 loose stools per day).
.Subjects with known or confirmed distant tumor metastasis. 7.Subjects with rectal obstruction and significant bleeding. 8.Subjects with history of surgery or trauma: major surgery within 8 weeks prior to screening, such as laparotomy, thoracotomy, organ resection, etc (excluding diagnostic surgical procedures); severe, non-healing wounds, ulcers, or fractures within 8 weeks prior to screening; minor surgery within 7 days prior to screening (excluding diagnostic surgical procedures).
.Subjects with other serious conditions that may restrict their participation in the trial (e.g., progressive infection, uncontrolled diabetes or uncontrolled hypertension, serious cardiac dysfunction or angina, active autoimmune disease, etc.).
0.Subjects with active infection as determined by positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
1.Subjects with other uncontrolled active infections (Grade CTCAE V5.0 \>2), who require treatment with IV antimicrobial therapy, and subjects with active tuberculosis, and subjects undergoing anti syphilis treatment.