Chronic Radiation ProctitisPhase 3ACRONNCT06837597
Jianzhong Qushi in Chronic RRI
A Phase 3 study testing Jianzhong Qushi Formula in people with Chronic Radiation Proctitis, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
This study is a multicenter, randomized, double-blind, placebo-controlled trial. Patients diagnosed as CRP and without TCM history will be enrolled and randomly assigned to either the treatment group (receiving standard care plus Jianzhong Qushi Formula, 100 ml bid, *28days) or the control group (receiving standard… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Radiation Proctitis
- What is being tested?
- Jianzhong Qushi Formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2025to 31 Jan 2029
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 85 years old
- ECOG score ≤ 2
- Pathologically confirmed malignant tumor
- Received pelvic radiotherapy, and it has been ≥ 3 months since the end of radiotherapy ;
- Meet the diagnostic criteria for chronic radiation proctitis in the "2023 Edition of the Practice Guidelines for the Prevention and Treatment of Radiation Proctitis" or the "2023 Edition of the Expert Consensus on the Diagnosis and Treatment of Radiation Intestinal Injury in Traditional Chinese and Western Medicine in China", with an international grading of level 1 - 2
- Meet the syndrome of spleen deficiency , and the syndrome differentiation is determined according to the "2017 Edition of the Expert Consensus on the Diagnosis and Treatment of Radiation Proctitis (Intestinal Syndrome) in Traditional Chinese Medicine" formulated by the Oncology Branch of the China Association of Traditional Chinese Medicine : Basic Syndrome PRO Scale of Spleen Deficiency (meeting 2 main symptoms or 1 main symptom* + 2 secondary symptoms#).
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- Hemoglobin ≥ 100 g / L, neutrophils ≥ 1.5 × 10^9^ / L
- Serum creatinine ≤ 1.25 times the upper normal limit (UNL)
- Total bilirubin ≤ 1.5 times UNL, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times UNL
- The patient has signed the informed consent form
- The patient agrees to cooperate with the follow - up. *Main symptoms included abdominal distension ,anorexia,tenesmus, unsatisfactory bowel movement and fatigue.
- Secondary symptoms included spontaneous sweating, dizziness,feeling of heaviness in the head, feeling of heaviness in the body, nausea and palpitations.
Who cannot join
- Other causes of enteritis cannot be ruled out
- The relevant symptoms existed before radiotherapy and did not worsen after treatment
- Allergy to more than 3 components of the Western medicine used in this study or the formula of Jianzhong Qushi Formula
- Tumor progression requiring urgent anti-tumor treatment
- Urgent surgical or endoscopic treatment is needed
- Has already entered other clinical studies targeting RRI
- Nursing or pregnant women
- Those who may interfere with the study evaluation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Jianzhong Qushi Formula for Treating Chronic Radiation Induced Proctitis : a Multicenter, Prospective, Randomized Controlled Clinical Trial
This study is a multicenter, randomized, double-blind, placebo-controlled trial. Patients diagnosed as CRP and without TCM history will be enrolled and randomly assigned to either the treatment group (receiving standard care plus Jianzhong Qushi Formula, 100 ml bid, *28days) or the control group (receiving standard care plus placebo 100 ml bid, *28days). All of the patients received both The primary endpoint is the clinical response rate, defined as fulfilling one of the following, RTOG grade reduction, ① RTOG/EORTC grade reduction; ② ≥1 symptom downgraded by CTCAE v5.0; ③ Symptom improvement according to TCM symptom standards .The secondary endpoints included TCM syndrome score reduction rate, LENT/SOMA score changes, changes in gut microbiota, quality of life(QoL) , etc. Totally, 168 patients (84 in each group) will be enrolled.
Read the detailed description
Both the treatment group and the control group are given standard treatment as recommended by the "2023 Edition of the Practice Guidelines for the Prevention and Treatment of Radiation Proctitis" or the "2018 Edition of the Expert Consensus on the Diagnosis and Treatment of Radiation Proctitis in China", such as sucralfate/steroids/loperamide according to symptoms.
① Treatment Group: Administer Jianzhong Qushi Formula, 100ml per dose, twice daily, taken before breakfast and after dinner, for a total of 28 days.
② Control Group: Administer a simulated Chinese medicine placebo, 100ml per dose, twice daily, taken before breakfast and after dinner, for a total of 28 days.
Observational medication
Jianzhong Qushi Formula (Patent No.: ZL202210097886.0) Composition:
- Monarch medicines (jun yao): Codonopsis (Dang Shen) tonifies the spleen and strengthens the body, serving as the monarch medicine.
- Minister medicines (chen yao): Atractylodes Macrocephala (Bai Zhu) is heavily used to dry dampness, transform phlegm, strengthen the spleen, and boost energy, along with Pinellia (Ban Xia) which is good at descending adverse qi and stopping vomiting, drying dampness and strengthening the spleen; both serve as the minister medicines.
- Assistant medicines (zuo yao): Poria (Fu Ling), Tangerine Peel (Chen Pi), and Amomum Tsao-ko (Cao Guo): serve to promote diuresis and reduce dampness to stop diarrhea, regulate qi to relieve abdominal pain, and dry dampness to resolve phlegm; Syzygium aromaticum (Ding Xiang) and Magnolia Officinalis (Hou Po) regulate qi and strengthen the spleen, Aucklandia Lappa (Mu Xiang) has a fragrant aroma that dries dampness, awakens the spleen, and harmonizes the middle burner, also assisting Amomum Tsao-ko and Tangerine Peel in drying dampness and resolving phlegm; Aspergillus Oryzae (Shen Qu) enters the spleen and stomach meridians, has the function of promoting digestion and appetite, and also regulates qi and resolves dampness, harmonizing the spleen and stomach; Codonopsis Pilosula (Bai Lian) regulates qi; Taraxacum Mongolicum (Pu Gong Ying) and Bletilla Stripping (Bai Ji) are combined to clear heat and detoxify, reduce swelling and disperse blood stasis, detoxify and resolve blood stasis obstruction, all serving as the assistant medicines.
- Guide medicines(shi yao): Glycyrrhiza Uralensis (Zhi Gan Cao) harmonizes all the medicines and serves as the guide medicines.
- Conditions
- Chronic Radiation Proctitis
- Being tested
- Jianzhong Qushi Formula, Placebo
- Keywords
- Chinese Tradiational Medicine, Chronic Radiation Proctitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jianzhong Qushi FormulaDrug
Jianzhong Qushi Formula (A Chinese traditional formula, approved by Chinese Patent, No. ZL202210097886.0)
PlaceboDrug
A simulated Chinese medicine placebo, with similar appearance and smell to Jianzhong Qushi Formula.
| Study group | Role | What they receive |
|---|---|---|
| Jianpi AnChang Group | Experimental | Jianzhong Qushi Formula, 100ml twice daily, taken before breakfast and after supper orally, for 28 days. Receives: Drug: Jianzhong Qushi Formula |
| Placebo Group | Placebo comparator | Simulated Chinese medicine placebo, 100ml twice daily, taken before breakfast and after supper orally, for 28 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
① A downgrade in the RTOG/EORTC radiation proctitis grading; ② A downgrade in the evaluation of ≥1 radiation enteritis - related symptom according to the National Cancer Center of the United States Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0 ); ③ Syndrome: alleviation of 2 main symptoms or 1 main symptom + 2 secondary symptoms
Measured: 1-month, 3-month, 6-month
Secondary outcomes (4)
Change of TCM syndrome scores: Calculated as (Pre-treatment Syndrome Score - Post-treatment Syndrome Score) / Pre-treatment Syndrome Score×100%. (Refer to the relevant standards in the "Guiding Principles for Clinical Research on New Traditional
Higher means better
Measured: 1-month, 3-month, 6-month
Changes in Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) scales
Fewer score means better
Measured: 1-month, 3-month, 6-month
Changes in Quality of Life Scores
Higher score means better
Measured: 1-month, 3-month, 6-month
Changes in intestinal flora
Measured: 1-month, 3-month, 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start15 Mar 2025 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Radiation ProctitisStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yirui Zhai,MD., Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Li Feng, MD., Study chair, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837597
- Sponsor's protocol ID
- No.24/520-4800
- Acronym
- ACRON
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing may be limited by agreements with sponsors, collaborators, or regulatory bodies, as well as jurisdictional laws governing data protection , for academic use only (non-commercial, non-political).
Publications
Tabaja L, Sidani SM. Management of Radiation Proctitis. Dig Dis Sci. 2018 Sep;63(9):2180-2188. doi: 10.1007/s10620-018-5163-8.
PubMed 29948565Denton A, Forbes A, Andreyev J, Maher EJ. Non surgical interventions for late radiation proctitis in patients who have received radical radiotherapy to the pelvis. Cochrane Database Syst Rev. 2002;(1):CD003455. doi: 10.1002/14651858.CD003455.
PubMed 11869662Liu L, Xiao N, Liang J. Comparative efficacy of oral drugs for chronic radiation proctitis - a systematic review. Syst Rev. 2023 Aug 22;12(1):146. doi: 10.1186/s13643-023-02294-2.
PubMed 37608385Sahebnasagh A, Ghasemi A, Akbari J, Alipour A, Lashkardoost H, Ala S, Hosseinimehr SJ, Salehifar E. Prevention of acute radiation-induced Proctitis by Aloe vera: a prospective randomized, double-blind, placebo controlled clinical trial in Pelvic Cancer patients. BMC Complement Med Ther. 2020 May 13;20(1):146. doi: 10.1186/s12906-020-02935-2.
PubMed 32404169Vanneste BG, Van De Voorde L, de Ridder RJ, Van Limbergen EJ, Lambin P, van Lin EN. Chronic radiation proctitis: tricks to prevent and treat. Int J Colorectal Dis. 2015 Oct;30(10):1293-303. doi: 10.1007/s00384-015-2289-4. Epub 2015 Jul 23.
PubMed 26198994Clarke RE, Tenorio LM, Hussey JR, Toklu AS, Cone DL, Hinojosa JG, Desai SP, Dominguez Parra L, Rodrigues SD, Long RJ, Walker MB. Hyperbaric oxygen treatment of chronic refractory radiation proctitis: a randomized and controlled double-blind crossover trial with long-term follow-up. Int J Radiat Oncol Biol Phys. 2008 Sep 1;72(1):134-143. doi: 10.1016/j.ijrobp.2007.12.048. Epub 2008 Mar 14.
PubMed 18342453
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jianzhong Qushi Formula for Treating Chronic Radiation Induced Proctitis : a Multicenter, Prospective, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06837597
- Acronym / sponsor ID
- ACRON / No.24/520-4800
- Conditions
- Chronic Radiation Proctitis
- Keywords
- Chinese Tradiational Medicine, Chronic Radiation Proctitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 20 Feb 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 study is a multicenter, randomized, double-blind, placebo-controlled trial. Patients diagnosed as CRP and without TCM history will be enrolled and randomly assigned to either the treatment group (receiving standard care plus Jianzhong Qushi Formula, 100 ml bid, *28days) or the control group (receiving standard care plus placebo 100 ml bid, *28days). All of the patients received both The primary endpoint is the clinical response rate, defined as fulfilling one of the following, RTOG grade reduction, ① RTOG/EORTC grade reduction; ② ≥1 symptom downgraded by CTCAE v5.0; ③ Symptom improvement according to TCM symptom standards .The secondary endpoints included TCM syndrome score reduction rate, LENT/SOMA score changes, changes in gut microbiota, quality of life(QoL) , etc. Totally, 168 patients (84 in each group) will be enrolled.
Detailed description
Both the treatment group and the control group are given standard treatment as recommended by the "2023 Edition of the Practice Guidelines for the Prevention and Treatment of Radiation Proctitis" or the "2018 Edition of the Expert Consensus on the Diagnosis and Treatment of Radiation Proctitis in China", such as sucralfate/steroids/loperamide according to symptoms.
① Treatment Group: Administer Jianzhong Qushi Formula, 100ml per dose, twice daily, taken before breakfast and after dinner, for a total of 28 days.
② Control Group: Administer a simulated Chinese medicine placebo, 100ml per dose, twice daily, taken before breakfast and after dinner, for a total of 28 days.
Observational medication
Jianzhong Qushi Formula (Patent No.: ZL202210097886.0) Composition:
- Monarch medicines (jun yao): Codonopsis (Dang Shen) tonifies the spleen and strengthens the body, serving as the monarch medicine.
- Minister medicines (chen yao): Atractylodes Macrocephala (Bai Zhu) is heavily used to dry dampness, transform phlegm, strengthen the spleen, and boost energy, along with Pinellia (Ban Xia) which is good at descending adverse qi and stopping vomiting, drying dampness and strengthening the spleen; both serve as the minister medicines.
- Assistant medicines (zuo yao): Poria (Fu Ling), Tangerine Peel (Chen Pi), and Amomum Tsao-ko (Cao Guo): serve to promote diuresis and reduce dampness to stop diarrhea, regulate qi to relieve abdominal pain, and dry dampness to resolve phlegm; Syzygium aromaticum (Ding Xiang) and Magnolia Officinalis (Hou Po) regulate qi and strengthen the spleen, Aucklandia Lappa (Mu Xiang) has a fragrant aroma that dries dampness, awakens the spleen, and harmonizes the middle burner, also assisting Amomum Tsao-ko and Tangerine Peel in drying dampness and resolving phlegm; Aspergillus Oryzae (Shen Qu) enters the spleen and stomach meridians, has the function of promoting digestion and appetite, and also regulates qi and resolves dampness, harmonizing the spleen and stomach; Codonopsis Pilosula (Bai Lian) regulates qi; Taraxacum Mongolicum (Pu Gong Ying) and Bletilla Stripping (Bai Ji) are combined to clear heat and detoxify, reduce swelling and disperse blood stasis, detoxify and resolve blood stasis obstruction, all serving as the assistant medicines.
- Guide medicines(shi yao): Glycyrrhiza Uralensis (Zhi Gan Cao) harmonizes all the medicines and serves as the guide medicines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jianpi AnChang Group | Experimental | Drug: Jianzhong Qushi FormulaJianzhong Qushi Formula, 100ml twice daily, taken before breakfast and after supper orally, for 28 days. |
| Placebo Group | Placebo comparator | Drug: PlaceboSimulated Chinese medicine placebo, 100ml twice daily, taken before breakfast and after supper orally, for 28 days. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18 - 85 years old
- ECOG score ≤ 2
- Pathologically confirmed malignant tumor
- Received pelvic radiotherapy, and it has been ≥ 3 months since the end of radiotherapy ;
- Meet the diagnostic criteria for chronic radiation proctitis in the "2023 Edition of the Practice Guidelines for the Prevention and Treatment of Radiation Proctitis" or the "2023 Edition of the Expert Consensus on the Diagnosis and Treatment of Radiation Intestinal Injury in Traditional Chinese and Western Medicine in China", with an international grading of level 1 - 2
Key exclusion criteria (8 listed)
- Other causes of enteritis cannot be ruled out
- The relevant symptoms existed before radiotherapy and did not worsen after treatment
- Allergy to more than 3 components of the Western medicine used in this study or the formula of Jianzhong Qushi Formula
- Tumor progression requiring urgent anti-tumor treatment
- Urgent surgical or endoscopic treatment is needed
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 |
|---|---|---|
| Jianzhong Qushi FormulaJianzhong Qushi Formula (A Chinese traditional formula, approved by Chinese Patent, No. ZL202210097886.0) | Drug | Jianpi AnChang Group |
| PlaceboA simulated Chinese medicine placebo, with similar appearance and smell to Jianzhong Qushi Formula. | Drug | Placebo Group |
Primary outcome
Response rate
Time frame: 1-month, 3-month, 6-month
① A downgrade in the RTOG/EORTC radiation proctitis grading; ② A downgrade in the evaluation of ≥1 radiation enteritis - related symptom according to the National Cancer Center of the United States Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0 ); ③ Syndrome: alleviation of 2 main symptoms or 1 main symptom + 2 secondary symptoms
4 secondary outcomes
Change of TCM syndrome scores: Calculated as (Pre-treatment Syndrome Score - Post-treatment Syndrome Score) / Pre-treatment Syndrome Score×100%. (Refer to the relevant standards in the "Guiding Principles for Clinical Research on New Traditional
Time frame: 1-month, 3-month, 6-month
Changes in Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) scales
Time frame: 1-month, 3-month, 6-month
Changes in Quality of Life Scores
Time frame: 1-month, 3-month, 6-month
Changes in intestinal flora
Time frame: 1-month, 3-month, 6-month
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 27 Feb 2025.
- Background: PubMed 29948565Tabaja L, Sidani SM. Management of Radiation Proctitis. Dig Dis Sci. 2018 Sep;63(9):2180-2188. doi: 10.1007/s10620-018-5163-8.
- Background: PubMed 11869662Denton A, Forbes A, Andreyev J, Maher EJ. Non surgical interventions for late radiation proctitis in patients who have received radical radiotherapy to the pelvis. Cochrane Database Syst Rev. 2002;(1):CD003455. doi: 10.1002/14651858.CD003455.
- Background: PubMed 37608385Liu L, Xiao N, Liang J. Comparative efficacy of oral drugs for chronic radiation proctitis - a systematic review. Syst Rev. 2023 Aug 22;12(1):146. doi: 10.1186/s13643-023-02294-2.
- Background: PubMed 32404169Sahebnasagh A, Ghasemi A, Akbari J, Alipour A, Lashkardoost H, Ala S, Hosseinimehr SJ, Salehifar E. Prevention of acute radiation-induced Proctitis by Aloe vera: a prospective randomized, double-blind, placebo controlled clinical trial in Pelvic Cancer patients. BMC Complement Med Ther. 2020 May 13;20(1):146. doi: 10.1186/s12906-020-02935-2.
- Background: PubMed 26198994Vanneste BG, Van De Voorde L, de Ridder RJ, Van Limbergen EJ, Lambin P, van Lin EN. Chronic radiation proctitis: tricks to prevent and treat. Int J Colorectal Dis. 2015 Oct;30(10):1293-303. doi: 10.1007/s00384-015-2289-4. Epub 2015 Jul 23.
- Background: PubMed 18342453Clarke RE, Tenorio LM, Hussey JR, Toklu AS, Cone DL, Hinojosa JG, Desai SP, Dominguez Parra L, Rodrigues SD, Long RJ, Walker MB. Hyperbaric oxygen treatment of chronic refractory radiation proctitis: a randomized and controlled double-blind crossover trial with long-term follow-up. Int J Radiat Oncol Biol Phys. 2008 Sep 1;72(1):134-143. doi: 10.1016/j.ijrobp.2007.12.048. Epub 2008 Mar 14.
- Individual participant dataSharing planned: Undecided. Data sharing may be limited by agreements with sponsors, collaborators, or regulatory bodies, as well as jurisdictional laws governing data protection , for academic use only (non-commercial, non-political).
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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.
Li Feng, MD. study chair
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Jianzhong Qushi Formula in people with Chronic Radiation Proctitis, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
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 12 inclusion and 8 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 27 Feb 2025. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yirui Zhai, MD. (+86-10-87788058, januarywind@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 1-month, 3-month, 6-month). 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 NCT06837597, which also lists 6 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 27 Feb 2025.