Locally Advanced Rectal CancerPhase 2AK104-IIT-13NCT05794750

Assess the Efficacy of Radiotherapy and Sequential Chemotherapy and AK104 Before TME Surgery for Local CRC（AK104-IIT-13）

A Phase 2 study testing AK104 injection, TME surgery and Capecitabine in people with Locally Advanced Rectal Cancer, run by JIN JING.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

This study is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of preoperative short-course radiotherapy combined with AK104 and chemotherapy + TME surgery in patients with advanced rectal cancer. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Locally Advanced Rectal Cancer
What is being tested?: AK104 injection, TME surgery and Capecitabine
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: No sites listed yet
Study dates: 24 Apr 2023to 24 Apr 2027
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

1. Age 18-75 years old, gender is not limited;
2. Stage II/III under MRI or endoscopic ultrasound ;
3. Fiber colonoscopy or diagnosis examination, the lower boundary of the lesion is 15m ≤ from the margin;
4. Rectal adenocarcinoma confirmed or revisited by pathology;
5. Karl Fischer score ≥ 80 points or ECOG score of 0-1;
6. Meet the following laboratory diagnostic indicators: hemoglobin ≥ 100g/L, white blood cell ≥ 3.5×109/L; neutrophils≥ 1.5×109/L, platelet ≥ 100×109/L; creatinine ≤ 1.0× upper limit of normal (UNL), urea nitrogen (BUN) ≤ 1.0× upper limit of normal (UNL); Alanine aminotransferase (ALT) ≤1.5× upper limit of normal (UNL); Aspartate aminotransferase (AST) ≤1.5× upper limit of normal (UNL); Alkaline phosphatase (ALP) ≤1.5× upper limit of normal (UNL); Total bilirubin (TBIL) ≤ 1.5× upper limit of normal (UNL); urine protein (-); Clotting time is normal.

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7. No history of allergy to 5-Fu drugs, no history of allergy to platinum drugs;
8. With primary rectal cancer required to undergo surgery (except palliative ostomy), chemotherapy or other anti-tumor therapy before diagnosis to enrollment;
9. Not received radiation before;
10. Sign the informed consent form.

Who cannot join

1. Previous anti-PD-1/L1 and anti-CTLA-4 immune drugs or other immunoassay drugs;
2. With severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc.;
3. Symptomatic interstitial lung disease or active infection/non-infectious pneumonia;
4. Patients have risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer or other known risk factors for intestinal perforation;
5. History of other malignant tumors, excluding curable non-melanogenic skin cancer and carcinoma in situ of the cervix;
6. Active infection, heart failure, myocardial infarction, unstable angina or unstable arrhythmia within 6 months;

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7. Physical examination or clinical laboratory findings that the investigator believes may interfere with the results or increase the patient's risk of treatment complications, or other uncontrollable diseases;
8. Breastfeeding or pregnant women;
9. Congenital or acquired immunodeficiency diseases including human immunodeficiency virus (HIV), or organ transplantation, allogeneic stem cell transplantation;
10. Known active hepatitis B virus (HBV), hepatitis C virus (HCV), active tuberculosis infection;
11. Vaccinated against tumors, or received other vaccines within 4 weeks before starting treatment (Note: Because the seasonal influenza vaccine for injection is mostly an inactivated vaccine, it is allowed to be vaccinated, while intranasal preparations are usually live attenuated vaccines, so it is not allowed)
12. Use other immunological agents, chemotherapy drugs, drugs in other clinical studies, and long-term cortisol therapy are not enrolled
13. With mental illness, substance abuse, and social problems that affect compliance will not be enrolled after a doctor's review
14. Allergic or contraindicated to the treatment of drugs.

About this study

Official title: A Single-arm, Multicenter, Phase II Study Evaluating the Efficacy and Safety of Preoperative Short-course Radiotherapy Followed by Sequential Chemotherapy and AK104 for Locally Advanced Rectal Cancer

Read the detailed description

Studies included a screening period (no more than 28 days after participants signed informed consent form to 28 days before first dose), treatment (receiving appropriate treatment until disease progression, intolerable toxicity, withdrawal of informed consent, death or study end, whichever occurs first), and follow-up (including safety follow-up and survival follow-up).

Eligible subjects will receive short-course radiotherapy (SCRT), IMRT/VMAT, pelvic 25Gy/5f/1 week. Two weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: AK104 10 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed). Patients are not recommended to enter the organ preservation observation; If the efficacy after preoperative chemoradiotherapy is evaluated as clinical complete remission (cCR) and the patient strongly refuses surgery, the patient should be informed of the risk of recurrence and ask the patient to sign a rejection of surgery. Medication safety is assessed and, depending on the severity of adverse events (AEs) and drug relevance, investigators will take steps to ensure subject safety. After surgery (or patients who strongly refuse surgery) there is a 30- and 90-day safety follow-up, and survival assessments are performed every 3 months to obtain survival information and collect new tumor treatment information until the death of the participant, withdrawal of informed consent, or the end of the study, whichever occurs first.

Conditions: Locally Advanced Rectal Cancer
Being tested: AK104 injection, TME surgery, Capecitabine, Oxaliplatin
Keywords: AK104, colorectal cancer, Pelvic short-course radiotherapy, TME surgery, pCR
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AK104 injectionDrug
Also called Immunotherapy
Eligible subjects will receive short-course radiotherapy (SCRT), IMRT/VMAT, pelvic 25Gy/5f/1 week. Two weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: AK104 10 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed).
TME surgeryProcedure or surgery
Also called Surgery
Eligible subjects will receive short-course radiotherapy (SCRT), IMRT/VMAT, pelvic 25Gy/5f/1 week. Two weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: AK104 10 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed).
CapecitabineDrug
Also called Chemotherapy drug
Eligible subjects will receive short-course radiotherapy (SCRT), IMRT/VMAT, pelvic 25Gy/5f/1 week. Two weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: AK104 10 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed).
OxaliplatinDrug
Also called Chemotherapy drug
Eligible subjects will receive short-course radiotherapy (SCRT), IMRT/VMAT, pelvic 25Gy/5f/1 week. Two weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: AK104 10 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed).

Study groups in NCT05794750
Study group	Role	What they receive
AK104 injection++chemotherapy	Experimental	Local CRC with short-course radiotherapy followed by sequential chemotherapy and AK104 Receives: Drug: AK104 injection; Procedure: TME surgery; Drug: Capecitabine; Drug: Oxaliplatin
TME surgery	Experimental	Local CRC with short-course radiotherapy followed by sequential chemotherapy and AK104 Receives: Drug: AK104 injection; Procedure: TME surgery; Drug: Capecitabine; Drug: Oxaliplatin
chemotherapy	Experimental	Local CRC with short-course radiotherapy followed by sequential chemotherapy and AK104 Receives: Drug: AK104 injection; Procedure: TME surgery; Drug: Capecitabine; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Pathologic complete response rate (pCR)
To assess the result from pathology report
Measured: From date of randomization until the date of end of treatment,about 18 weeks.

Secondary outcomes (4)

Major pathologic response rate (MPR)
To assess the result from pathology report
Measured: From date of randomization until the date of end of treatment,about 18 weeks.
3-years DFS rate
To compute the length between end of treatment and relapse
Measured: From date of randomization until the date of first documented disease relapse or date of death from any cause, whichever came first about 3years..
3-years OS rate
To compute the length between end of treatment and death
Measured: From date of randomization until date of death from any cause,about 3 years.
Incidence and severity of adverse events (AEs) and clinically meaningful abnormal laboratory test results
To assess the result from inspection paper during the trail
Measured: From date of randomization until the date of end of treatment,about 18 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Apr 202324 Apr 2027

First posted3 Apr 2023
Study start24 Apr 2023 (estimated)
Primary completion24 Apr 2027 (estimated)
Study completion24 Apr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05794750
Sponsor's protocol ID: 1244030031951808X0
Acronym: AK104-IIT-13
Status last verified: Apr 2023
First submitted: 19 Feb 2023
Last updated: 6 Apr 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Xu T, Feng L, Zhang W, Li H, Ma H, Abulimiti M, Tan Y, Deng F, Huang W, Zou S, Kang W, Jiang L, Wang Y, Hu C, Chen Y, Zhou H, Tang Y, Jin J. The efficacy and safety of short-course radiotherapy followed by sequential chemotherapy and Cadonilimab for locally advanced rectal cancer: a protocol of a phase II study. BMC Cancer. 2024 Apr 19;24(1):501. doi: 10.1186/s12885-024-12254-1.
PubMed 38641773

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Not yet recruitingObservational study
Multidimensional Study Designed to Develop a Methodological Framework Based on MRI Data to Predict Pathological Complete Response (pCR) in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Treatment
Rectal Cancer, Chemoradiotherapy
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 1
Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer
Locally Advanced Rectal Carcinoma, Rectal Adenocarcinoma
Not yet recruitingPhase 3
Sintilimab Combined With LCCRT Followed by Capeox Chemotherapy in pMMR/MSS/MSI-L Locally Advanced Rectal Cancer
Locally Advanced Rectal Cancer

All Locally Advanced Rectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-arm, Multicenter, Phase II Study Evaluating the Efficacy and Safety of Preoperative Short-course Radiotherapy Followed by Sequential Chemotherapy and AK104 for Locally Advanced Rectal Cancer
ClinicalTrials.gov ID: NCT05794750
Acronym / sponsor ID: AK104-IIT-13 / 1244030031951808X0
Conditions: Locally Advanced Rectal Cancer
Keywords: AK104, colorectal cancer, Pelvic short-course radiotherapy, TME surgery, pCR
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 50 participants (estimated)
Lead sponsor: JIN JINGUniversity, hospital or other
Study start: 24 Apr 2023 (estimated)
Primary completion: 24 Apr 2027 (estimated)
Study completion: 24 Apr 2027 (estimated)
First posted: 3 Apr 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
AK104 injection++chemotherapy	Experimental	Drug: AK104 injection, Procedure: TME surgery, Drug: Capecitabine, Drug: OxaliplatinLocal CRC with short-course radiotherapy followed by sequential chemotherapy and AK104
TME surgery	Experimental	Drug: AK104 injection, Procedure: TME surgery, Drug: Capecitabine, Drug: OxaliplatinLocal CRC with short-course radiotherapy followed by sequential chemotherapy and AK104
chemotherapy	Experimental	Drug: AK104 injection, Procedure: TME surgery, Drug: Capecitabine, Drug: OxaliplatinLocal CRC with short-course radiotherapy followed by sequential chemotherapy and AK104

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

1. Age 18-75 years old, gender is not limited;
2. Stage II/III under MRI or endoscopic ultrasound ;
3. Fiber colonoscopy or diagnosis examination, the lower boundary of the lesion is 15m ≤ from the margin;
4. Rectal adenocarcinoma confirmed or revisited by pathology;
5. Karl Fischer score ≥ 80 points or ECOG score of 0-1;

Key exclusion criteria (14 listed)

1. Previous anti-PD-1/L1 and anti-CTLA-4 immune drugs or other immunoassay drugs;
2. With severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc.;
3. Symptomatic interstitial lung disease or active infection/non-infectious pneumonia;
4. Patients have risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer or other known risk factors for intestinal perforation;
5. History of other malignant tumors, excluding curable non-melanogenic skin cancer and carcinoma in situ of the cervix;

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
AK104 injectionAlso: ImmunotherapyEligible subjects will receive short-course radiotherapy (SCRT), IMRT/VMAT, pelvic 25Gy/5f/1 week. Two weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: AK104 10 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed).	Drug	AK104 injection++chemotherapy, TME surgery, chemotherapy
TME surgeryAlso: SurgeryEligible subjects will receive short-course radiotherapy (SCRT), IMRT/VMAT, pelvic 25Gy/5f/1 week. Two weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: AK104 10 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed).	Procedure or surgery	AK104 injection++chemotherapy, TME surgery, chemotherapy
CapecitabineAlso: Chemotherapy drugEligible subjects will receive short-course radiotherapy (SCRT), IMRT/VMAT, pelvic 25Gy/5f/1 week. Two weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: AK104 10 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed).	Drug	AK104 injection++chemotherapy, TME surgery, chemotherapy
OxaliplatinAlso: Chemotherapy drugEligible subjects will receive short-course radiotherapy (SCRT), IMRT/VMAT, pelvic 25Gy/5f/1 week. Two weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: AK104 10 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed).	Drug	AK104 injection++chemotherapy, TME surgery, chemotherapy

Primary outcome

Pathologic complete response rate (pCR)
Time frame: From date of randomization until the date of end of treatment,about 18 weeks.
To assess the result from pathology report

4 secondary outcomes

Major pathologic response rate (MPR)
Time frame: From date of randomization until the date of end of treatment,about 18 weeks.
3-years DFS rate
Time frame: From date of randomization until the date of first documented disease relapse or date of death from any cause, whichever came first about 3years..
3-years OS rate
Time frame: From date of randomization until date of death from any cause,about 3 years.
Incidence and severity of adverse events (AEs) and clinically meaningful abnormal laboratory test results
Time frame: From date of randomization until the date of end of treatment,about 18 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 6 Apr 2023.
Derived from this study: PubMed 38641773Xu T, Feng L, Zhang W, Li H, Ma H, Abulimiti M, Tan Y, Deng F, Huang W, Zou S, Kang W, Jiang L, Wang Y, Hu C, Chen Y, Zhou H, Tang Y, Jin J. The efficacy and safety of short-course radiotherapy followed by sequential chemotherapy and Cadonilimab for locally advanced rectal cancer: a protocol of a phase II study. BMC Cancer. 2024 Apr 19;24(1):501. doi: 10.1186/s12885-024-12254-1.

Related trials for Locally Advanced Rectal Cancer

RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Not yet recruitingObservational study
Multidimensional Study Designed to Develop a Methodological Framework Based on MRI Data to Predict Pathological Complete Response (pCR) in Patients With Locally Advanced Rectal Cancer After Neoadjuvant Treatment
Rectal Cancer, Chemoradiotherapy
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 1
Short Course Radiation Therapy and Combination Chemotherapy for the Treatment of Stage II-III Rectal Cancer
Locally Advanced Rectal Carcinoma, Rectal Adenocarcinoma
Not yet recruitingPhase 3
Sintilimab Combined With LCCRT Followed by Capeox Chemotherapy in pMMR/MSS/MSI-L Locally Advanced Rectal Cancer
Locally Advanced Rectal Cancer

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 AK104 injection, TME surgery and Capecitabine in people with Locally Advanced Rectal Cancer, run by JIN JING.

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 10 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 6 Apr 2023. 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?

Pathologic complete response rate (pCR) (time frame: From date of randomization until the date of end of treatment,about 18 weeks.). 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 NCT05794750, which also lists 1 linked publication.

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 6 Apr 2023.