Mid-low Locally Advanced Rectal CancerPhase 2rSIFN-coNCT07662278
rSIFN-co in Combination With Total Neo-adjuvant Therapy in Subjects With Mid-low Locally Advanced Rectal Cancer
A Phase 2 study testing Recombinant Super-Compound Interferon (rSIFN-co) and Total Neo-adjuvant therapy in people with Mid-low Locally Advanced Rectal Cancer, run by Sichuan Huiyang Life Science and Technology Corporation.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mid-low Locally Advanced Rectal Cancer
- What is being tested?
- Recombinant Super-Compound Interferon (rSIFN-co) and Total Neo-adjuvant therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jun 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Male and female subjects ≥18 years of age and having BMI ≥ 17 kg/m2. 2.Subjects with histologically or cytologically confirmed mid-low locally advanced rectal cancer, with tumor location within 12 cm from the anal verge, as per UICC classification, and who are scheduled to undergo TNT in the opinion of the investigator 3.Subjects having rectal cancer with pMMR/MSS tumor type and TNM stage: T3, N any, M0; T1-2, N1-2, M0; T4, N any, M0 or locally unresectable or medically inoperable or subjects who are eligible for sphincter sparing surgery.
- 4.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.
- 7.Subjects with normal organ functions prior to enrollment in study:
- Blood routine examination
- WBC: ≥ 4×109/L;
- Hemoglobin content (HB) ≥ 9.0 g/dl (no blood transfusion within 28 days);
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- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L;
- Platelets (PLT) ≥ 100 × 109/L.
- Biochemical examination * Total bilirubin (TBIL) ≤ 1.5 × ULN;
- ALT and AST ≤ 2.5 × ULN; Creatinine clearance (CrCl) ≥ 60ml/min using the Cockcroft Gault formula 8.Adequate coagulation function, defined as international normalized ratio (INR) and prothrombin time (PT) ≤ 1.5 × ULN; 9.Female subjects with negative serum pregnancy test at screening and negative urine pregnancy test at baseline.
- 10.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.
- Acceptable methods of contraception are:
- Intrauterine device (IUD) or Intrauterine system (IUS)
- 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)
- Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 06 weeks prior to study participation
- Total abstinence (partial abstinence is not acceptable). 11.Male subjects with female partners of reproductive potential must agree to use condoms (or any barrier method of contraception) throughout the study and for at least 3 months after receiving the final dose.
Who cannot join
- 1.Subjects with known hypersensitivity or contraindication to study drug or to any known component of study drug formulation.
- 2.Subjects who have received treatment with interferon and interferon-like therapy within 30 days prior to screening.
- 3.Subjects who had present or prior malignancy other than study indication (except cured basal or squamous cell carcinoma, cervical carcinoma).
- 4.Subjects who have received radiotherapy prior to screening or had a history of radiotherapy around the pelvic area.
- 5.Subjects with known or confirmed severe gastrointestinal inflammation, ileus, or chronic diarrhea (>3 loose stools per day).
- 6.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).
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- 9.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.).
- 10.Subjects with active infection as determined by positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- Note: Subjects with controlled HIV, HBV, or HCV infection by antiretroviral therapy will not be excluded.
- 11.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.
- 12.Subjects with a history of severe skin disease. 13.Subjects with known or confirmed presence of other uncontrollable benign diseases of the lung, liver or kidney and known or confirmed presence of any infection.
- 14.Subjects with any other medical condition or serious inter-current illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.
- 15.Pregnant or lactating women, or female subjects unwilling to use any form of contraception during the study.
- 16.Subjects with history of alcohol or drug abuse.
About this study
Official title: A Randomized, Multi-Center, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of Recombinant Super-Compound Interferon (rSIFN-co) in Combination With Total Neo-adjuvant Therapy, in Subjects With Mid-low Locally Advanced Rectal Cancer
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).
- Conditions
- Mid-low Locally Advanced Rectal Cancer
- Being tested
- Recombinant Super-Compound Interferon (rSIFN-co), Total Neo-adjuvant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Super-Compound Interferon (rSIFN-co)Drug
Subjects will receive the reconstituted rSIFN-co lyophilized powder via rectum and anus, twice a week
Total Neo-adjuvant therapyDrug
each subject will receive short-course radiotherapy (RT) (25 Gy in 5 fractions) followed by chemotherapy (6 cycles of CAPEOX), after 2-week rest.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (TNT regimen + 1800 µg/day of rSIFN-co treatment) | Experimental | Subjects will receive the reconstituted rSIFN-co lyophilized powder via rectum and anus, twice a week, and TNT regimen. In the TNT approach, each subject will receive short-course radiotherapy (RT) (25 Gy in 5 fractions) followed by chemotherapy (6 cycles of CAPEOX), after 2-week rest Receives: Drug: Recombinant Super-Compound Interferon (rSIFN-co); Drug: Total Neo-adjuvant therapy |
| Arm B (TNT regimen only). | Active comparator | Subject will receive short-course radiotherapy (RT) (25 Gy in 5 fractions) followed by chemotherapy (6 cycles of CAPEOX), after 2-week rest Receives: Drug: Total Neo-adjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the complete response rate at the end of treatment period
complete response is defined as the proportion of subjects with pathological complete response (pCR) or clinical complete response (cCR).
Measured: at the end of treatment period (approximately at week 25)
Secondary outcomes (4)
To evaluate the proportion of subjects achieving ypT0
Proportion of subjects achieving ypT0 according to the TNM staging system of the AJCC cancer staging manual, at the end of treatment period
Measured: at the end of treatment period (approximately at week 25)
To evaluate the proportion of the subjects with tumor down-staging
defined as reduction of at least one level in T or N staging between the baseline MRI and histopathological staging, without any evidence of upstaging or disease progression, after treatment with rSIFN-co when given in combination with TNT.
Measured: at the end of treatment period (approximately at week 25)
To evaluate the percentage of subjects who are medically inoperable at baseline and who are undergoing surgery after treatment
Percentage of subjects who are medically inoperable at baseline and who are undergoing surgery after treatment with rSIFN-co when given in combination with TNT
Measured: at the end of treatment period (approximately at week 25)
To determine the occurrence of any AEs/SAEs during the study duration
To determine the occurrence of any AEs/SAEs during the study duration, according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0)
Measured: through study completion, an average of 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mid-low Locally Advanced Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Huiyang Life Science and Technology Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662278
- Sponsor's protocol ID
- MW230024
- Acronym
- rSIFN-co
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-Center, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of Recombinant Super-Compound Interferon (rSIFN-co) in Combination With Total Neo-adjuvant Therapy, in Subjects With Mid-low Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT07662278
- Acronym / sponsor ID
- rSIFN-co / MW230024
- Conditions
- Mid-low Locally Advanced Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sichuan Huiyang Life Science and Technology CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (TNT regimen + 1800 µg/day of rSIFN-co treatment) | Experimental | Drug: Recombinant Super-Compound Interferon (rSIFN-co), Drug: Total Neo-adjuvant therapySubjects will receive the reconstituted rSIFN-co lyophilized powder via rectum and anus, twice a week, and TNT regimen. In the TNT approach, each subject will receive short-course radiotherapy (RT) (25 Gy in 5 fractions) followed by chemotherapy (6 cycles of CAPEOX), after 2-week rest |
| Arm B (TNT regimen only). | Active comparator | Drug: Total Neo-adjuvant therapySubject will receive short-course radiotherapy (RT) (25 Gy in 5 fractions) followed by chemotherapy (6 cycles of CAPEOX), after 2-week rest |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 1.Male and female subjects ≥18 years of age and having BMI ≥ 17 kg/m2. 2.Subjects with histologically or cytologically confirmed mid-low locally advanced rectal cancer, with tumor location within 12 cm from the anal verge, as per UICC classification, and who are scheduled to undergo TNT in the opinion of the investigator 3.Subjects having rectal cancer with pMMR/MSS tumor type and TNM stage: T3, N any, M0; T1-2, N1-2, M0; T4, N any, M0 or locally unresectable or medically inoperable or subjects who are eligible for sphincter sparing surgery.
- 4.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.
- 10.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)
- Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent)
Key exclusion criteria (14 listed)
- 2.Subjects who have received treatment with interferon and interferon-like therapy within 30 days prior to screening.
- 3.Subjects who had present or prior malignancy other than study indication (except cured basal or squamous cell carcinoma, cervical carcinoma).
- 4.Subjects who have received radiotherapy prior to screening or had a history of radiotherapy around the pelvic area.
- 5.Subjects with known or confirmed severe gastrointestinal inflammation, ileus, or chronic diarrhea (>3 loose stools per day).
- 6.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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Super-Compound Interferon (rSIFN-co)Subjects will receive the reconstituted rSIFN-co lyophilized powder via rectum and anus, twice a week | Drug | Arm A (TNT regimen + 1800 µg/day of rSIFN-co treatment) |
| Total Neo-adjuvant therapyeach subject will receive short-course radiotherapy (RT) (25 Gy in 5 fractions) followed by chemotherapy (6 cycles of CAPEOX), after 2-week rest. | Drug | Arm A (TNT regimen + 1800 µg/day of rSIFN-co treatment), Arm B (TNT regimen only). |
Primary outcome
To evaluate the complete response rate at the end of treatment period
Time frame: at the end of treatment period (approximately at week 25)
complete response is defined as the proportion of subjects with pathological complete response (pCR) or clinical complete response (cCR).
4 secondary outcomes
To evaluate the proportion of subjects achieving ypT0
Time frame: at the end of treatment period (approximately at week 25)
To evaluate the proportion of the subjects with tumor down-staging
Time frame: at the end of treatment period (approximately at week 25)
To evaluate the percentage of subjects who are medically inoperable at baseline and who are undergoing surgery after treatment
Time frame: at the end of treatment period (approximately at week 25)
To determine the occurrence of any AEs/SAEs during the study duration
Time frame: through study completion, an average of 25 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Super-Compound Interferon (rSIFN-co) and Total Neo-adjuvant therapy in people with Mid-low Locally Advanced Rectal Cancer, run by Sichuan Huiyang Life Science and Technology Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the complete response rate at the end of treatment period (time frame: at the end of treatment period (approximately at week 25)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.