Chronic Radiation-induced ProctitisPhase 2NCT07065175
KANGFUPEN Liquid Dressing for Chronic Radiation-Induced Rectal Injury
A Phase 2 study testing Kangfupen (liquid dressing) retention enema administration in people with Chronic Radiation-induced Proctitis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This clinical trial aims to evaluate the efficacy and safety of Kangfupen (a topical liquid dressing) in treating chronic radiation-induced proctitis (RTOG Grade 2 or higher). The key questions we aim to answer are: 1. Does Kangfupen improve LENT-SOMA rectal injury scores after 3 months of treatment? 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Radiation-induced Proctitis
- What is being tested?
- Kangfupen (liquid dressing) retention enema administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- Aug 2025to Jan 2029
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully voluntary with decision-making capacity
- 18-80 years old
- Completed pelvic radiotherapy for malignancy ≥3 months prior
- Evidence of chronic radiation-induced rectal injury (RTOG Grade ≥2)
- Evidence of radiation-induced rectal injury on colonoscopy (within 3 months, Vienna endoscopic score ≥1)
- No prior surgery
- ECOG score 0-2
- Estimated survival ≥1 year
Who cannot join
- Primary rectal tumours or pelvic malignancies with rectal involvement
- Uncontrolled, recurrent, or metastatic tumours
- Concurrent anticancer therapies including radiotherapy, chemotherapy, targeted therapy, immunotherapy and traditional Chinese medicine with anti-tumour properties
- Patients with intestinal fistula, perforation, or obstruction
- History of electrocautery treatment within 1 month
- Recent medication use (within 2 weeks): traditional Chinese medicine enemas, mesalazine (oral or rectal) and other anti-inflammatory bowel medications
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- History of superoxide dismutase allergy
- Pre-existing chronic colitis, ulcerative colitis, or nonspecific proctitis
- Connective tissue diseases requiring long-term corticosteroid therapy
- Pregnant or lactating women
- Active infection or fever
- Other severe comorbidities potentially affecting trial compliance: unstable cardiac disease requiring treatment, renal disorders, chronic hepatitis, poorly controlled diabetes and psychiatric illnesses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital & Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730
Weiping Wang, Doctor, 86-69154081, jluwangweiping@163.com
Ke Hu, Doctor
About this study
Official title: KANGFUPEN (Liquid Dressing) for the Treatment of Chronic Radiation-Induced Rectal Injury: A Prospective, Single-Arm, Multicenter Study
This clinical trial aims to evaluate the efficacy and safety of Kangfupen (a topical liquid dressing) in treating chronic radiation-induced proctitis (RTOG Grade 2 or higher). The key questions we aim to answer are:
- Does Kangfupen improve LENT-SOMA rectal injury scores after 3 months of treatment?
- Does Kangfupen reduce endoscopic inflammation (Vienna score) and symptoms (RTOG/CTCAE grades)?
- What adverse events occur with Kangfupen therapy? Kangfupen liquid dressing (50 mL/once daily) will be administered as retention enema for 3-6 months, adjusted based on lesion location.
Read more
Researchers will evaluate the following outcomes to assess Kangfupen's efficacy and safety in treating chronic radiation proctitis:
- Change in LENT-SOMA rectal injury score (baseline vs. 3 months).
- Changes in Vienna endoscopic score, RTOG/CTCAE grades, and IBDQ quality-of-life scores.
- Symptom improvement rate and time to complete remission.
Participant will:
- Undergo baseline and 3-month endoscopic evaluations.
- Complete symptom diaries and quality-of-life questionnaires.
- Attend regular clinic visits for safety monitoring.
Read the detailed description
Baseline Assessments
All enrolled patients must complete the following evaluations:
- Medical history including primary tumor type, histopathology, staging and radiotherapy details (timing, technique, and total dose)
- Physical examination
- ECOG performance status
- Laboratory tests including complete blood count, stool occult blood, liver/kidney function and tumor markers
- Pelvic scans to exclude tumor recurrence/progression
- Full colonoscopy with photographic documentation. Images every 5cm from anus to splenic flexure, and at sites of severe mucosal reaction additionally
- Grading based on LENT-SOMA, RTOG, and CTCAE v5.0 criteria
Treatment protocol Kangfupen (liquid dressing) retention enema
- Dosage: 50 mL once daily for 3-6 months
- Administration depth: Determined by colonoscopy findings Enema preparation \& administration 1. Reconstitution:
- Transfer liquid from plastic to brown glass vial
- Shake vigorously to dissolve lyophilized powder
- Return solution to plastic bottle and shake again 2. Delivery: <!-- -->
- Position: Left lateral decubitus with waste basin
- Slowly instill 50 mL into rectum
- Retain for ≥30 minutes, rotating positions every 15 minutes (left/right lateral, supine, knee-chest)
Concomitant therapies Permitted: probiotics, smectite, antibiotics, stool softeners Prohibited: 5-ASA drugs (mesalazine/sulfasalazine), endoscopic hemostasis (e.g., argon plasma coagulation), formaldehyde/HBO/surgery/fecal microbiota transplant, other enema therapies.
Toxicity monitoring Potential adverse events include allergic reactions and mechanical injury (bleeding/perforation). Required Actions include immediately discontinuing treatment and reporting to the principal investigating site within 24 hours.
All adverse events will be assessed using CTCAE v5.0 criteria.
Follow-up schedule Month 1-2: LENT-SOMA, RTOG/CTCAE grades, IBDQ, symptom improvement evaluation Month 3: Above + sigmoidoscopy with Vienna scoring Every 6 months after month 6: sigmoidoscopy + all scales + physician's global assessment of treatment efficacy
- Conditions
- Chronic Radiation-induced Proctitis
- Being tested
- Kangfupen (liquid dressing) retention enema administration
- Keywords
- Radiotherapy complications, Chronic radiation-induced proctitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangfupen (liquid dressing) retention enema administrationDrug
Dosage: 50 mL per administration, once daily Duration: 3-6 months of continuous therapy
Procedure:
Enema depth determined by colonoscopy-identified lesion location Administered as retention enema (minimum 30-minute retention time)
| Study group | Role | What they receive |
|---|---|---|
| All enrolled patients | Experimental | All enrolled patients receive the same investigational intervention (Kangfupen liquid dressing enema). Scientific comparison is achieved through Pre- vs. post-treatment (3/6/12mo) parameter changes (e.g., ΔLENT-SOMA). Receives: Drug: Kangfupen (liquid dressing) retention enema administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LENT-SOMA rectal radiation injury scores from baseline to 3 months post-treatment
Treatment response is defined as:
- Effective: Decrease in LENT-SOMA score compared to baseline
- Ineffective: No change or increase in LENT-SOMA score versus baseline
Measured: From enrolment to 3 months post-treatment
Secondary outcomes (4)
Change in Vienna endoscopic scores from baseline to post-treatment
Treatment response is defined as:
- Effective: Any decrease in Vienna endoscopic score at 3 months post-treatment compared to baseline
- Ineffective: Stable or increased score compared to baseline
Measured: From enrolment to 3 months post-treatment
Changes in RTOG and CTCAE grading from baseline to post-treatment assessments
Treatment response is defined as:
- Efficient: Any decrease in either RTOG radiation toxicity grade or CTCAE adverse event grade from baseline
- Inefficient: No improvement or worsening in both grading systems
Measured: From enrolment to 3 months post-treatment
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Function and Bleeding Scores from baseline to post-treatment
Treatment response is defined as:
- Efficient: Any decrease in IBDQ bowel function and bleeding scores post-treatment compared to baseline
- Inefficient: No change or increase in IBDQ bowel function and bleeding scores versus baseline
Measured: From enrolment to 3 months post-treatment
Post-treatment symptom improvement rate
Symptoms are categorized into:
Complete remission: Complete resolution of clinical symptoms (e.g., rectal bleeding, diarrhea, tenesmus) Partial remission: Significant improvement in symptoms, but not complete resolution Stable disease: No significant change in symptoms (no improvement or worsening) Progression: Worsening of clinical symptoms
Treatment response is defined as:
- Effective: Complete remission or partial remission
- Ineffective: Stable disease or progression
Measured: From enrolment to 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Radiation-induced ProctitisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- The efficacy assessment employs a repeated-measures design with intra-individual comparisons between baseline and post-treatment timepoints.
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University, Peking University First Hospital, Tianjin Medical University Cancer Institute and Hospital, Beijing Rectum Hospital, Jilin City Hospital of Chemical Industry
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065175
- Sponsor's protocol ID
- PUMCHKANGFUPENG
- Status last verified
- May 2025
- First submitted
- 25 May 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu J, Li X, Huang M, Zhu H, Tan Y, He X, Sun Z, Cheng H, Li F, Jiang P, Lou H, Ke G, Cao X, Zhu L, Xie P, Yan J, Zhang F. Application of Recombinant Human Superoxide Dismutase in Radical Concurrent Chemoradiotherapy for Cervical Cancer to Prevent and Treat Radiation-induced Acute Rectal Injury: A Multicenter, Randomized, Open-label, Prospective Trial. Int J Radiat Oncol Biol Phys. 2024 Nov 1;120(3):720-729. doi: 10.1016/j.ijrobp.2024.04.070. Epub 2024 May 4.
PubMed 38705489Tohidinezhad F, Willems Y, Berbee M, Limbergen EV, Verhaegen F, Dekker A, Traverso A. Prediction models for brachytherapy-induced rectal toxicity in patients with locally advanced pelvic cancers: a systematic review. J Contemp Brachytherapy. 2022 Aug;14(4):411-422. doi: 10.5114/jcb.2022.119427. Epub 2022 Aug 31.
PubMed 36199943Michalski JM, Yan Y, Watkins-Bruner D, Bosch WR, Winter K, Galvin JM, Bahary JP, Morton GC, Parliament MB, Sandler HM. Preliminary toxicity analysis of 3-dimensional conformal radiation therapy versus intensity modulated radiation therapy on the high-dose arm of the Radiation Therapy Oncology Group 0126 prostate cancer trial. Int J Radiat Oncol Biol Phys. 2013 Dec 1;87(5):932-8. doi: 10.1016/j.ijrobp.2013.07.041. Epub 2013 Oct 8.
PubMed 24113055Wang CJ, Huang EY, Sun LM, Chen HC, Fang FM, Hsu HC, Changchien CC, Leung SW. Clinical comparison of two linear-quadratic model-based isoeffect fractionation schemes of high-dose-rate intracavitary brachytherapy for cervical cancer. Int J Radiat Oncol Biol Phys. 2004 May 1;59(1):179-89. doi: 10.1016/j.ijrobp.2003.10.025.
PubMed 15093915
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KANGFUPEN (Liquid Dressing) for the Treatment of Chronic Radiation-Induced Rectal Injury: A Prospective, Single-Arm, Multicenter Study
- ClinicalTrials.gov ID
- NCT07065175
- Acronym / sponsor ID
- PUMCHKANGFUPENG
- Conditions
- Chronic Radiation-induced Proctitis
- Keywords
- Radiotherapy complications, Chronic radiation-induced proctitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University, Peking University First Hospital, Tianjin Medical University Cancer Institute and Hospital, Beijing Rectum Hospital, Jilin City Hospital of Chemical Industry
- Study start
- Aug 2025 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 15 Jul 2025 (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 clinical trial aims to evaluate the efficacy and safety of Kangfupen (a topical liquid dressing) in treating chronic radiation-induced proctitis (RTOG Grade 2 or higher). The key questions we aim to answer are:
- Does Kangfupen improve LENT-SOMA rectal injury scores after 3 months of treatment?
- Does Kangfupen reduce endoscopic inflammation (Vienna score) and symptoms (RTOG/CTCAE grades)?
- What adverse events occur with Kangfupen therapy? Kangfupen liquid dressing (50 mL/once daily) will be administered as retention enema for 3-6 months, adjusted based on lesion location.
Researchers will evaluate the following outcomes to assess Kangfupen's efficacy and safety in treating chronic radiation proctitis:
- Change in LENT-SOMA rectal injury score (baseline vs. 3 months).
- Changes in Vienna endoscopic score, RTOG/CTCAE grades, and IBDQ quality-of-life scores.
- Symptom improvement rate and time to complete remission.
Participant will:
- Undergo baseline and 3-month endoscopic evaluations.
- Complete symptom diaries and quality-of-life questionnaires.
- Attend regular clinic visits for safety monitoring.
Detailed description
Baseline Assessments
All enrolled patients must complete the following evaluations:
- Medical history including primary tumor type, histopathology, staging and radiotherapy details (timing, technique, and total dose)
- Physical examination
- ECOG performance status
- Laboratory tests including complete blood count, stool occult blood, liver/kidney function and tumor markers
- Pelvic scans to exclude tumor recurrence/progression
- Full colonoscopy with photographic documentation. Images every 5cm from anus to splenic flexure, and at sites of severe mucosal reaction additionally
- Grading based on LENT-SOMA, RTOG, and CTCAE v5.0 criteria
Treatment protocol Kangfupen (liquid dressing) retention enema
- Dosage: 50 mL once daily for 3-6 months
- Administration depth: Determined by colonoscopy findings Enema preparation \& administration 1. Reconstitution:
- Transfer liquid from plastic to brown glass vial
- Shake vigorously to dissolve lyophilized powder
- Return solution to plastic bottle and shake again 2. Delivery: <!-- -->
- Position: Left lateral decubitus with waste basin
- Slowly instill 50 mL into rectum
- Retain for ≥30 minutes, rotating positions every 15 minutes (left/right lateral, supine, knee-chest)
Concomitant therapies Permitted: probiotics, smectite, antibiotics, stool softeners Prohibited: 5-ASA drugs (mesalazine/sulfasalazine), endoscopic hemostasis (e.g., argon plasma coagulation), formaldehyde/HBO/surgery/fecal microbiota transplant, other enema therapies.
Toxicity monitoring Potential adverse events include allergic reactions and mechanical injury (bleeding/perforation). Required Actions include immediately discontinuing treatment and reporting to the principal investigating site within 24 hours.
All adverse events will be assessed using CTCAE v5.0 criteria.
Follow-up schedule Month 1-2: LENT-SOMA, RTOG/CTCAE grades, IBDQ, symptom improvement evaluation Month 3: Above + sigmoidoscopy with Vienna scoring Every 6 months after month 6: sigmoidoscopy + all scales + physician's global assessment of treatment efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The efficacy assessment employs a repeated-measures design with intra-individual comparisons between baseline and post-treatment timepoints.
| Arm | Type | Receives |
|---|---|---|
| All enrolled patients | Experimental | Drug: Kangfupen (liquid dressing) retention enema administrationAll enrolled patients receive the same investigational intervention (Kangfupen liquid dressing enema). Scientific comparison is achieved through Pre- vs. post-treatment (3/6/12mo) parameter changes (e.g., ΔLENT-SOMA). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Fully voluntary with decision-making capacity
- 18-80 years old
- Completed pelvic radiotherapy for malignancy ≥3 months prior
- Evidence of chronic radiation-induced rectal injury (RTOG Grade ≥2)
- Evidence of radiation-induced rectal injury on colonoscopy (within 3 months, Vienna endoscopic score ≥1)
Key exclusion criteria (12 listed)
- Primary rectal tumours or pelvic malignancies with rectal involvement
- Uncontrolled, recurrent, or metastatic tumours
- Concurrent anticancer therapies including radiotherapy, chemotherapy, targeted therapy, immunotherapy and traditional Chinese medicine with anti-tumour properties
- Patients with intestinal fistula, perforation, or obstruction
- History of electrocautery treatment within 1 month
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 |
|---|---|---|
| Kangfupen (liquid dressing) retention enema administrationDosage: 50 mL per administration, once daily Duration: 3-6 months of continuous therapy Procedure: Enema depth determined by colonoscopy-identified lesion location Administered as retention enema (minimum 30-minute retention time) | Drug | All enrolled patients |
Primary outcome
Change in LENT-SOMA rectal radiation injury scores from baseline to 3 months post-treatment
Time frame: From enrolment to 3 months post-treatment
Treatment response is defined as: 1. Effective: Decrease in LENT-SOMA score compared to baseline 2. Ineffective: No change or increase in LENT-SOMA score versus baseline
4 secondary outcomes
Change in Vienna endoscopic scores from baseline to post-treatment
Time frame: From enrolment to 3 months post-treatment
Changes in RTOG and CTCAE grading from baseline to post-treatment assessments
Time frame: From enrolment to 3 months post-treatment
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Function and Bleeding Scores from baseline to post-treatment
Time frame: From enrolment to 3 months post-treatment
Post-treatment symptom improvement rate
Time frame: From enrolment to 3 months post-treatment
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 15 Jul 2025.
- Background: PubMed 38705489Zhu J, Li X, Huang M, Zhu H, Tan Y, He X, Sun Z, Cheng H, Li F, Jiang P, Lou H, Ke G, Cao X, Zhu L, Xie P, Yan J, Zhang F. Application of Recombinant Human Superoxide Dismutase in Radical Concurrent Chemoradiotherapy for Cervical Cancer to Prevent and Treat Radiation-induced Acute Rectal Injury: A Multicenter, Randomized, Open-label, Prospective Trial. Int J Radiat Oncol Biol Phys. 2024 Nov 1;120(3):720-729. doi: 10.1016/j.ijrobp.2024.04.070. Epub 2024 May 4.
- Background: PubMed 36199943Tohidinezhad F, Willems Y, Berbee M, Limbergen EV, Verhaegen F, Dekker A, Traverso A. Prediction models for brachytherapy-induced rectal toxicity in patients with locally advanced pelvic cancers: a systematic review. J Contemp Brachytherapy. 2022 Aug;14(4):411-422. doi: 10.5114/jcb.2022.119427. Epub 2022 Aug 31.
- Background: PubMed 24113055Michalski JM, Yan Y, Watkins-Bruner D, Bosch WR, Winter K, Galvin JM, Bahary JP, Morton GC, Parliament MB, Sandler HM. Preliminary toxicity analysis of 3-dimensional conformal radiation therapy versus intensity modulated radiation therapy on the high-dose arm of the Radiation Therapy Oncology Group 0126 prostate cancer trial. Int J Radiat Oncol Biol Phys. 2013 Dec 1;87(5):932-8. doi: 10.1016/j.ijrobp.2013.07.041. Epub 2013 Oct 8.
- Background: PubMed 15093915Wang CJ, Huang EY, Sun LM, Chen HC, Fang FM, Hsu HC, Changchien CC, Leung SW. Clinical comparison of two linear-quadratic model-based isoeffect fractionation schemes of high-dose-rate intracavitary brachytherapy for cervical cancer. Int J Radiat Oncol Biol Phys. 2004 May 1;59(1):179-89. doi: 10.1016/j.ijrobp.2003.10.025.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Kangfupen (liquid dressing) retention enema administration in people with Chronic Radiation-induced Proctitis, run by Peking Union Medical College Hospital at 1 site in China.
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 8 inclusion and 12 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 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Ke Hu, Doctor (86-010-69155482, huke8000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LENT-SOMA rectal radiation injury scores from baseline to 3 months post-treatment (time frame: From enrolment to 3 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07065175, which also lists 4 linked publications.
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 15 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.