Anal Squamous Cell CancerPhase 2ChaseNCT07555678
Chemoradiotherapy and Anti-PD-1 Antibody in Anal Squamous Cell Cancer：Chase
A Phase 2 study testing PD-1 Inhibitor + Chemotherapy in people with Anal Squamous Cell Cancer, run by Fudan University at 1 site in China.
Trial summary
Squamous cell carcinoma (SCC) of the anus is a rare malignancy. For localized anal squamous cell carcinoma , definitive chemoradiotherapy is the standard treatment. Patients who do not achieve complete response （CR）or experience recurrence require radical surgery with permanent colostomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anal Squamous Cell Cancer
- What is being tested?
- PD-1 Inhibitor + Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 31 Dec 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- This study consists of four cohorts. Inclusion and exclusion criteria comprise general inclusion criteria, cohort-specific inclusion criteria, general exclusion criteria, and cohort-specific exclusion criteria.
- General Inclusion Criteria Age 18-75 years, male or female; Pathologically confirmed squamous cell carcinoma of the anal canal or perianal region; ECOG performance status 0-1 and life expectancy ≥ 3 months; Adequate organ function:(1) Absolute neutrophil count ≥ 1.5 ×10⁹/L; platelet count ≥ 100 ×10⁹/L; hemoglobin ≥ 9 g/dL; serum albumin ≥ 3 g/dL;(2) Thyroid-stimulating hormone (TSH) ≤ 1 × upper limit of normal (ULN), with normal T3 and T4;(3) Bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2 × ULN;(4) Serum creatinine ≤ 1.5 × ULN, creatinine clearance ≥ 60 mL/min;(5) International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN, unless the patient is on anticoagulation with PT within the expected therapeutic range; activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN; No severe comorbidities expected to limit survival to < 5 years; Female subjects: negative pregnancy test (if of childbearing potential) or permanently non-childbearing potential; Sexually active males and females of childbearing potential must agree to use effective contraception during the entire study period and for 12 months after completion of study treatment; Written and dated informed consent indicating the patient has been informed of all relevant aspects of the study; No concurrent medical condition requiring mandatory hormone replacement therapy; Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Inclusion Criteria for Cohort 1 In addition to the general inclusion criteria:（1）Tumor < 5 cm (T1-2) and negative regional lymph nodes (N-) on physical examination or contrast-enhanced pelvic MRI;(2) No prior anti-tumor therapy.
- Inclusion Criteria for Cohort 2 In addition to the general inclusion criteria:(1) No residual tumor detectable on physical examination or imaging after local excision;(2) No prior anti-tumor therapy including radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
- Inclusion Criteria for Cohort 3 In addition to the general inclusion criteria:(1) Tumor ≥ 5 cm (T3), or invasion of adjacent organs (T4), or regional lymph node positivity (N+) in mesorectal, presacral, internal/external iliac, or inguinal lymph node regions on physical examination or contrast-enhanced pelvic MRI;(2) No prior anti-tumor therapy.
- Inclusion Criteria for Cohort 4 In addition to the general inclusion criteria:(1) Initial distant metastasis (M1) (liver, lung, bone, distant lymph nodes, etc.) confirmed by chest/abdominal CT or PET-CT,or pelvic recurrence after prior treatment, with or without distant metastasis.
Who cannot join
- Patients with any of the following criteria are ineligible for this study:
- Pathological diagnosis of other anal tumors, such as gastrointestinal stromal tumor, lymphoma, melanoma, etc.; Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies; Previous or concurrent malignancy, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma; Active autoimmune disease or history of autoimmune disease (including but not limited to interstitial lung disease, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); excluding: autoimmune-mediated hypothyroidism on a stable dose of thyroid replacement therapy; type 1 diabetes mellitus on a stable dose of insulin; vitiligo; childhood asthma/allergy that resolved with no intervention required in adulthood; History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency disorders, history of organ transplantation or allogeneic bone marrow transplantation; History of interstitial lung disease (excluding radiation pneumonitis not requiring corticosteroid therapy) or non-infectious pneumonitis; Active pulmonary tuberculosis confirmed by medical history or CT scan, active tuberculosis within 1 year prior to enrollment, or inactive tuberculosis for more than 1 year without standard anti-tuberculosis treatment; Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL) or active hepatitis C (positive anti-HCV antibody with HCV RNA above the lower limit of detection); Severe cardiac, pulmonary, hepatic, or renal dysfunction; History of psychoactive substance abuse, alcoholism, or drug addiction; Any other conditions judged by the investigator that may compromise patient safety or study compliance, including severe medical or psychiatric disorders requiring concurrent treatment, significant laboratory abnormalities, or other social or family factors.
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, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Zhen Zhang, MD, +86-021-64175590, zhen_zhang@fudan.edu.cn
About this study
Official title: Chinese Multicenter Phase II Trial of Chemoradiotherapy and Anti-PD-1 Antibody in Anal Squamous Cell Cancer：Chase
Squamous cell carcinoma (SCC) of the anus is a rare malignancy. For localized anal squamous cell carcinoma , definitive chemoradiotherapy is the standard treatment. Patients who do not achieve complete response （CR）or experience recurrence require radical surgery with permanent colostomy.
In previous studies of anal squamous cell carcinoma （ASCC）, although favorable response rates were achieved after concurrent chemoradiotherapy, high rates of local recurrence and distant metastasis were also observed in patients with locally advanced disease, which adversely affect patient survival.
Read more
Clinical studies have demonstrated that single-agent PD-1/PD-L1 inhibitors, including nivolumab and pembrolizumab, show promising efficacy in advanced anal squamous cell carcinoma. Given the high recurrence rate associated with current concurrent chemoradiotherapy regimens and the characteristics of the immune microenvironment in anal cancer, the combination of immunotherapy with concurrent chemoradiotherapy is expected to improve therapeutic outcomes.
Therefore, we designed this prospective, multicenter, phase II clinical study to investigate the efficacy and safety of concurrent chemoradiotherapy combined with immune checkpoint inhibitors in anal cancer. This study aims to enhance the therapeutic effect for patients with locally advanced, recurrent, or metastatic anal squamous cell carcinoma and reduce adverse events in patients with high-risk factors after local excision or in early-stage disease.
The primary endpoints are local tumor control rate, overall survival, and radiation-related toxicity. The results will provide evidence for subsequent randomized controlled trials.
- Conditions
- Anal Squamous Cell Cancer
- Being tested
- PD-1 Inhibitor + Chemotherapy
- Keywords
- Anal Squamous Cell Cancer, immunotherapy, chemoradiotherapy
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 Inhibitor + ChemotherapyDrug
Also called radiotherapy
chemotherapy and sintilimab
| Study group | Role | What they receive |
|---|---|---|
| Early stage anal squamous cell carcinoma | Experimental | Tumor size <5 cm (T1-2) and negative regional lymph nodes (N-) demonstrated by physical examination or contrast-enhanced pelvic MRI. After short-course radiotherapy, 4 cycles of albumin-bound paclitaxel plus platinum and sintilimab will be administered. Receives: Drug: PD-1 Inhibitor + Chemotherapy |
| local resection of anal squamous cell carcinoma | Experimental | Inclusion criteria：no residual tumor visible on physical examination or imaging after local excision.Pathology after local excision reveals high-risk factors, positive margins, or unknown margins.Following short-course radiotherapy, 4 cycles of albumin-bound paclitaxel plus platinum and sintilimab will be administered.Primary endpoint: Severe acute toxicity. Receives: Drug: PD-1 Inhibitor + Chemotherapy |
| Locally advanced anal squamous cell carcinoma | Experimental | Eligibility Criteria:Tumor ≥5 cm (T3) demonstrated by physical examination or contrast-enhanced pelvic MRI;or invasion of adjacent organs (T4);or regional lymph node positivity (N+) in the mesorectal, presacral, internal/external iliac, or inguinal lymph node regions.
Treatment:Long-course radiotherapy at 54-56 Gy,concurrent with 2 cycles of albumin-bound paclitaxel plus platinum.After completion of radiotherapy,4 cycles of albumin-bound paclitaxel plus platinum and sintilimab will be administered.
Primary Endpoint:Complete response rate (including cCR and pCR). Receives: Drug: PD-1 Inhibitor + Chemotherapy |
| Recurrent and metastatic anal squamous cell carcinoma | Experimental | Eligibility Criteria:Initial distant metastasis (M1) in the liver, lung, bone, distant lymph nodes, or other sites confirmed by chest and abdominal CT or PET-CT;or pelvic recurrence after prior treatment, with or without distant metastasis.
Treatment:Radiotherapy to recurrent or metastatic lesions, followed by chemotherapy combined with sintilimab.
Primary Endpoint:12-month progression-free survival (PFS). Receives: Drug: PD-1 Inhibitor + Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
the primary endpoint of cohort 3 is CR rate including cCR and pCR
Measured: 1 month after the surgery or the decision of Watch and wait
Severe acute toxicity.
The primary endpoint for Cohort 1 (early anal squamous cell carcinoma) and Cohort 2 (post-local excision anal squamous cell carcinoma) is the rate of severe adverse events.
Measured: from the start of radiotherapy to 3 months after the start of radiotherapy
12-month progression-free survival (PFS).
The primary endpoint for Cohort 4 (recurrent or metastetic anal squamous cell carcinoma) is 12-month progression-free survival (PFS).
Measured: The proportion of patients who were alive and progression-free from the start of initial treatment up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Apr 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal Squamous Cell CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- chemoradiotherapy combined with immune checkpoint inhibitors in anal cancer.
- Masking
- None (open label)
- Enrolment
- 241 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen Zhang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555678
- Sponsor's protocol ID
- Chase1
- Acronym
- Chase
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Multicenter Phase II Trial of Chemoradiotherapy and Anti-PD-1 Antibody in Anal Squamous Cell Cancer：Chase
- ClinicalTrials.gov ID
- NCT07555678
- Acronym / sponsor ID
- Chase / Chase1
- Conditions
- Anal Squamous Cell Cancer
- Keywords
- Anal Squamous Cell Cancer, immunotherapy, chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 241 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Apr 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.
Squamous cell carcinoma (SCC) of the anus is a rare malignancy. For localized anal squamous cell carcinoma , definitive chemoradiotherapy is the standard treatment. Patients who do not achieve complete response （CR）or experience recurrence require radical surgery with permanent colostomy.
In previous studies of anal squamous cell carcinoma （ASCC）, although favorable response rates were achieved after concurrent chemoradiotherapy, high rates of local recurrence and distant metastasis were also observed in patients with locally advanced disease, which adversely affect patient survival.
Clinical studies have demonstrated that single-agent PD-1/PD-L1 inhibitors, including nivolumab and pembrolizumab, show promising efficacy in advanced anal squamous cell carcinoma. Given the high recurrence rate associated with current concurrent chemoradiotherapy regimens and the characteristics of the immune microenvironment in anal cancer, the combination of immunotherapy with concurrent chemoradiotherapy is expected to improve therapeutic outcomes.
Therefore, we designed this prospective, multicenter, phase II clinical study to investigate the efficacy and safety of concurrent chemoradiotherapy combined with immune checkpoint inhibitors in anal cancer. This study aims to enhance the therapeutic effect for patients with locally advanced, recurrent, or metastatic anal squamous cell carcinoma and reduce adverse events in patients with high-risk factors after local excision or in early-stage disease.
The primary endpoints are local tumor control rate, overall survival, and radiation-related toxicity. The results will provide evidence for subsequent randomized controlled trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- chemoradiotherapy combined with immune checkpoint inhibitors in anal cancer.
| Arm | Type | Receives |
|---|---|---|
| Early stage anal squamous cell carcinoma | Experimental | Drug: PD-1 Inhibitor + ChemotherapyTumor size <5 cm (T1-2) and negative regional lymph nodes (N-) demonstrated by physical examination or contrast-enhanced pelvic MRI. After short-course radiotherapy, 4 cycles of albumin-bound paclitaxel plus platinum and sintilimab will be administered. |
| local resection of anal squamous cell carcinoma | Experimental | Drug: PD-1 Inhibitor + ChemotherapyInclusion criteria：no residual tumor visible on physical examination or imaging after local excision.Pathology after local excision reveals high-risk factors, positive margins, or unknown margins.Following short-course radiotherapy, 4 cycles of albumin-bound paclitaxel plus platinum and sintilimab will be administered.Primary endpoint: Severe acute toxicity. |
| Locally advanced anal squamous cell carcinoma | Experimental | Drug: PD-1 Inhibitor + ChemotherapyEligibility Criteria:Tumor ≥5 cm (T3) demonstrated by physical examination or contrast-enhanced pelvic MRI;or invasion of adjacent organs (T4);or regional lymph node positivity (N+) in the mesorectal, presacral, internal/external iliac, or inguinal lymph node regions. Treatment:Long-course radiotherapy at 54-56 Gy,concurrent with 2 cycles of albumin-bound paclitaxel plus platinum.After completion of radiotherapy,4 cycles of albumin-bound paclitaxel plus platinum and sintilimab will be administered. Primary Endpoint:Complete response rate (including cCR and pCR). |
| Recurrent and metastatic anal squamous cell carcinoma | Experimental | Drug: PD-1 Inhibitor + ChemotherapyEligibility Criteria:Initial distant metastasis (M1) in the liver, lung, bone, distant lymph nodes, or other sites confirmed by chest and abdominal CT or PET-CT;or pelvic recurrence after prior treatment, with or without distant metastasis. Treatment:Radiotherapy to recurrent or metastatic lesions, followed by chemotherapy combined with sintilimab. Primary Endpoint:12-month progression-free survival (PFS). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- This study consists of four cohorts. Inclusion and exclusion criteria comprise general inclusion criteria, cohort-specific inclusion criteria, general exclusion criteria, and cohort-specific exclusion criteria.
- General Inclusion Criteria Age 18-75 years, male or female; Pathologically confirmed squamous cell carcinoma of the anal canal or perianal region; ECOG performance status 0-1 and life expectancy ≥ 3 months; Adequate organ function:(1) Absolute neutrophil count ≥ 1.5 ×10⁹/L; platelet count ≥ 100 ×10⁹/L; hemoglobin ≥ 9 g/dL; serum albumin ≥ 3 g/dL;(2) Thyroid-stimulating hormone (TSH) ≤ 1 × upper limit of normal (ULN), with normal T3 and T4;(3) Bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2 × ULN;(4) Serum creatinine ≤ 1.5 × ULN, creatinine clearance ≥ 60 mL/min;(5) International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN, unless the patient is on anticoagulation with PT within the expected therapeutic range; activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN; No severe comorbidities expected to limit survival to < 5 years; Female subjects: negative pregnancy test (if of childbearing potential) or permanently non-childbearing potential; Sexually active males and females of childbearing potential must agree to use effective contraception during the entire study period and for 12 months after completion of study treatment; Written and dated informed consent indicating the patient has been informed of all relevant aspects of the study; No concurrent medical condition requiring mandatory hormone replacement therapy; Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Inclusion Criteria for Cohort 1 In addition to the general inclusion criteria:（1）Tumor < 5 cm (T1-2) and negative regional lymph nodes (N-) on physical examination or contrast-enhanced pelvic MRI;(2) No prior anti-tumor therapy.
- Inclusion Criteria for Cohort 2 In addition to the general inclusion criteria:(1) No residual tumor detectable on physical examination or imaging after local excision;(2) No prior anti-tumor therapy including radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
- Inclusion Criteria for Cohort 3 In addition to the general inclusion criteria:(1) Tumor ≥ 5 cm (T3), or invasion of adjacent organs (T4), or regional lymph node positivity (N+) in mesorectal, presacral, internal/external iliac, or inguinal lymph node regions on physical examination or contrast-enhanced pelvic MRI;(2) No prior anti-tumor therapy.
Key exclusion criteria (2 listed)
- Pathological diagnosis of other anal tumors, such as gastrointestinal stromal tumor, lymphoma, melanoma, etc.; Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies; Previous or concurrent malignancy, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma; Active autoimmune disease or history of autoimmune disease (including but not limited to interstitial lung disease, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); excluding: autoimmune-mediated hypothyroidism on a stable dose of thyroid replacement therapy; type 1 diabetes mellitus on a stable dose of insulin; vitiligo; childhood asthma/allergy that resolved with no intervention required in adulthood; History of immunodeficiency, including positive HIV test, other acquired or congenital immunodeficiency disorders, history of organ transplantation or allogeneic bone marrow transplantation; History of interstitial lung disease (excluding radiation pneumonitis not requiring corticosteroid therapy) or non-infectious pneumonitis; Active pulmonary tuberculosis confirmed by medical history or CT scan, active tuberculosis within 1 year prior to enrollment, or inactive tuberculosis for more than 1 year without standard anti-tuberculosis treatment; Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL) or active hepatitis C (positive anti-HCV antibody with HCV RNA above the lower limit of detection); Severe cardiac, pulmonary, hepatic, or renal dysfunction; History of psychoactive substance abuse, alcoholism, or drug addiction; Any other conditions judged by the investigator that may compromise patient safety or study compliance, including severe medical or psychiatric disorders requiring concurrent treatment, significant laboratory abnormalities, or other social or family factors.
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 |
|---|---|---|
| PD-1 Inhibitor + ChemotherapyAlso: radiotherapychemotherapy and sintilimab | Drug | Early stage anal squamous cell carcinoma, Locally advanced anal squamous cell carcinoma, Recurrent and metastatic anal squamous cell carcinoma, local resection of anal squamous cell carcinoma |
Primary outcome
Complete response rate
Time frame: 1 month after the surgery or the decision of Watch and wait
the primary endpoint of cohort 3 is CR rate including cCR and pCR
Severe acute toxicity.
Time frame: from the start of radiotherapy to 3 months after the start of radiotherapy
The primary endpoint for Cohort 1 (early anal squamous cell carcinoma) and Cohort 2 (post-local excision anal squamous cell carcinoma) is the rate of severe adverse events.
12-month progression-free survival (PFS).
Time frame: The proportion of patients who were alive and progression-free from the start of initial treatment up to 12 months.
The primary endpoint for Cohort 4 (recurrent or metastetic anal squamous cell carcinoma) is 12-month progression-free survival (PFS).
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 29 Apr 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.
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 PD-1 Inhibitor + Chemotherapy in people with Anal Squamous Cell Cancer, run by Fudan University 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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: 1 month after the surgery or the decision of Watch and wait). The study lists 3 primary outcomes in all. 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 29 Apr 2026.