Esophageal Squamous Cell CarcinomaPhase 2NCT05174325
Effectiveness of Neoadjuvant Chemotherapy Combined With PD-1 Monoclonal Antibody in the Treatment of Operable Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Sintilimab + chemotherapy in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This study aims to evaluate the efficacy of sintilimab combined with concurrent chemotherapy as a neoadjuvant treatment for patients with operable esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Sintilimab + chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 1 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years old and ≤75 years old; 2) Patients with stage I~III thoracic esophageal squamous cell carcinoma diagnosed by histopathological examination (excluding mixed adenosquamous carcinoma and other pathological types); 3) ECOG PS score is 0 or 1; 4) According to RECIST v1.1 version, there is at least one measurable lesion; 5) It has sufficient organ and bone marrow function, defined as follows: 6) Blood routine: absolute neutrophil count (ANC)≥1.5×109/L; platelet count (PLT)≥100×109/L; hemoglobin content (HGB)≥9.0 g/dL. Liver function: Patients without liver metastases require serum total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN. Renal function: creatinine clearance rate (Ccr) ≥60 mL/min (calculated by Cockcroft/Gault formula): female: Ccr= (140-years) x body weight (kg) x 0.85 72 x serum creatinine (mg/dL) male: Ccr= (140-years) x body weight (kg) x 1.00 72 x serum creatinine (mg/dL). Adequate coagulation function is defined as the international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; if the subject is receiving anticoagulation therapy, as long as the PT is within the proposed range of anticoagulation drugs; 7) Expected survival time ≥ 12 weeks; 8) Sign a written informed consent form and be able to comply with the visit and related procedures stipulated in the plan.
Who cannot join
- 1) Refuse to participate; 2) Patients with esophageal squamous cell carcinoma who are diagnosed as stage IV or have surgical contraindications or refuse surgery; 3) Patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula; 4) Have previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody therapy, or any other antibodies targeting T cell costimulation or checkpoint pathways as specific targets or drug; 5) Participate in another interventional clinical study at the same time, unless participating in an observational (non-interventional) clinical study or in the follow-up phase of an interventional study; 6) Have received systemic systemic treatment with anti-tumor indications Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration; 7) Have used immunosuppressive drugs within 1 week before enrollment, excluding nasal spray, inhalation or other local glucocorticoids or physiological doses of systemic glucocorticoids (ie no more than 10mg/day prednisone Or equivalent doses of other glucocorticoids), or use hormones to prevent allergy to contrast agents; 8) Receive live attenuated vaccine within 4 weeks before the first dose of study treatment or plan to receive the live attenuated vaccine during the study period; Note: It is allowed to receive the inactivated virus vaccine for seasonal influenza by injection within 4 weeks before the first dose; but it is not allowed to receive Live attenuated influenza vaccine; 9) Major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment or expected major surgery during the study treatment period; 10) Prior to the first dose of study treatment, there was no recovery to the National Cancer Institute General Adverse Event Terminology version 5.0 (NCI CTCAE version 5.0) 0 or 1 toxicity (excluding hair loss, non-clinical) caused by previous anti-tumor therapy Significant and asymptomatic laboratory abnormalities); 11) Known active autoimmune disease and need symptomatic treatment or a history of the disease within the past 2 years (Vitiligo, psoriasis, hair loss or Grave's disease that does not require systemic treatment within the past 2 years, only need Patients with hypothyroidism under thyroid hormone replacement therapy and type I diabetes who only require insulin replacement therapy can be included in the group); 12) Known history of primary immunodeficiency; 13) Known to have active tuberculosis; 14) Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 15) Known to be allergic to any monoclonal antibody or chemotherapeutic drug (paclitaxel, cisplatin) preparations or excipient ingredients; 16) People with known HIV infection (HIV antibody positive); 17) Any arterial thromboembolic events, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack occurred within 6 months before being selected for treatment; 18) Significant malnutrition, such as intravenous supplementation of nutrient solutions; unless the malnutrition is corrected more than 4 weeks before the first dose of study treatment; 19) History of bowel obstruction or the following diseases: inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection, complicated by chronic diarrhea), Crohn's disease, ulcerative colitis; 20) Known to have acute or chronic active hepatitis B (HBsAg positive and HBV DNA viral load ≥103 copies/mL or >200IU/ml) or acute or chronic active hepatitis C HCV antibody positive and HCV RNA Positive); 21) Suffer from interstitial lung disease that requires steroid therapy; 22) Female patients who are pregnant or breastfeeding; 23) Other acute or chronic diseases, mental illnesses, or abnormal laboratory test values that may cause the following results: increase the risk related to study participation or study drug administration, or interfere with the interpretation of the study results, and the patients shall be treated according to the judgment of the investigator Listed as not eligible to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of soochow university
Suzhou, Jiangsu, 215000
Jun Zhao, 86-0512-67972216, zhaojia0327@126.com
About this study
Official title: Phase II Exploratory Study of the Effectiveness of Neoadjuvant Chemotherapy Combined With PD-1 Monoclonal Antibody in the Treatment of Esophageal Squamous Cell Carcinoma: a Prospective, Single-center, Single-arm Study
This study aims to evaluate the efficacy of sintilimab combined with concurrent chemotherapy as a neoadjuvant treatment for patients with operable esophageal squamous cell carcinoma. It will also evaluate the changes in the immune microenvironment of tumor specimens before and after the medication, and predict the operable period (stage I~III) Patients with thoracic esophageal squamous cell carcinoma were treated with neoadjuvant chemotherapy combined with PD-1 monoclonal antibody, and the effect of neoadjuvant chemotherapy combined with PD-1 monoclonal antibody was evaluated by detecting the changes of microbial diversity and metabolites in stool samples before and after treatment.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Sintilimab + chemotherapy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab + chemotherapyDrug
Biological : Sintilimab 100mg: 10ml Method of administration: 200mg IV D1 Q3W. Drug: Cisplatin Injection Specification: 75mg/m2, IV D1 Q3W. Drug: Albumin Paclitaxel Injection specifications: 260mg/m2, IV D1 Q3W.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Pre-operative Sintilimab + chemotherapy Receives: Drug: Sintilimab + chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete remission (PCR)
Primary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Measured: 4 weeks after surgery
Secondary outcomes (2)
Objective Response Rate (ORR)
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
Measured: 4 weeks after surgery
Radiographic response
To assess radiographic response to neoadjuvant pembrolizumab with concurrent chemoradiotherapy using RECIST 1.1.
Measured: From date of treatment allocation and during treatment period up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start1 Dec 2020
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jul 2022 (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 Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174325
- Sponsor's protocol ID
- 20211210
- Status last verified
- Dec 2021
- First submitted
- 13 Dec 2021
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang B, Shi H, Gong X, Yu J, Xiao C, Zhou B, Liang Z, Li X. Comparison of efficacy and safety between pembrolizumab combined with chemotherapy and simple chemotherapy in neoadjuvant therapy for esophageal squamous cell carcinoma. J Gastrointest Oncol. 2021 Oct;12(5):2013-2021. doi: 10.21037/jgo-21-610.
PubMed 34790369Kudo T, Hamamoto Y, Kato K, Ura T, Kojima T, Tsushima T, Hironaka S, Hara H, Satoh T, Iwasa S, Muro K, Yasui H, Minashi K, Yamaguchi K, Ohtsu A, Doki Y, Kitagawa Y. Nivolumab treatment for oesophageal squamous-cell carcinoma: an open-label, multicentre, phase 2 trial. Lancet Oncol. 2017 May;18(5):631-639. doi: 10.1016/S1470-2045(17)30181-X. Epub 2017 Mar 15.
PubMed 28314688Kojima T, Shah MA, Muro K, Francois E, Adenis A, Hsu CH, Doi T, Moriwaki T, Kim SB, Lee SH, Bennouna J, Kato K, Shen L, Enzinger P, Qin SK, Ferreira P, Chen J, Girotto G, de la Fouchardiere C, Senellart H, Al-Rajabi R, Lordick F, Wang R, Suryawanshi S, Bhagia P, Kang SP, Metges JP; KEYNOTE-181 Investigators. Randomized Phase III KEYNOTE-181 Study of Pembrolizumab Versus Chemotherapy in Advanced Esophageal Cancer. J Clin Oncol. 2020 Dec 10;38(35):4138-4148. doi: 10.1200/JCO.20.01888. Epub 2020 Oct 7.
PubMed 33026938van den Ende T, de Clercq NC, van Berge Henegouwen MI, Gisbertz SS, Geijsen ED, Verhoeven RHA, Meijer SL, Schokker S, Dings MPG, Bergman JJGHM, Haj Mohammad N, Ruurda JP, van Hillegersberg R, Mook S, Nieuwdorp M, de Gruijl TD, Soeratram TTD, Ylstra B, van Grieken NCT, Bijlsma MF, Hulshof MCCM, van Laarhoven HWM. Neoadjuvant Chemoradiotherapy Combined with Atezolizumab for Resectable Esophageal Adenocarcinoma: A Single-arm Phase II Feasibility Trial (PERFECT). Clin Cancer Res. 2021 Jun 15;27(12):3351-3359. doi: 10.1158/1078-0432.CCR-20-4443. Epub 2021 Jan 27.
PubMed 33504550
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Exploratory Study of the Effectiveness of Neoadjuvant Chemotherapy Combined With PD-1 Monoclonal Antibody in the Treatment of Esophageal Squamous Cell Carcinoma: a Prospective, Single-center, Single-arm Study
- ClinicalTrials.gov ID
- NCT05174325
- Acronym / sponsor ID
- 20211210
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Innovent Biologics (Suzhou) Co. Ltd.
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 30 Dec 2021 (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 aims to evaluate the efficacy of sintilimab combined with concurrent chemotherapy as a neoadjuvant treatment for patients with operable esophageal squamous cell carcinoma. It will also evaluate the changes in the immune microenvironment of tumor specimens before and after the medication, and predict the operable period (stage I~III) Patients with thoracic esophageal squamous cell carcinoma were treated with neoadjuvant chemotherapy combined with PD-1 monoclonal antibody, and the effect of neoadjuvant chemotherapy combined with PD-1 monoclonal antibody was evaluated by detecting the changes of microbial diversity and metabolites in stool samples before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Sintilimab + chemotherapyPre-operative Sintilimab + chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Age ≥18 years old and ≤75 years old; 2) Patients with stage I~III thoracic esophageal squamous cell carcinoma diagnosed by histopathological examination (excluding mixed adenosquamous carcinoma and other pathological types); 3) ECOG PS score is 0 or 1; 4) According to RECIST v1.1 version, there is at least one measurable lesion; 5) It has sufficient organ and bone marrow function, defined as follows: 6) Blood routine: absolute neutrophil count (ANC)≥1.5×109/L; platelet count (PLT)≥100×109/L; hemoglobin content (HGB)≥9.0 g/dL. Liver function: Patients without liver metastases require serum total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN. Renal function: creatinine clearance rate (Ccr) ≥60 mL/min (calculated by Cockcroft/Gault formula): female: Ccr= (140-years) x body weight (kg) x 0.85 72 x serum creatinine (mg/dL) male: Ccr= (140-years) x body weight (kg) x 1.00 72 x serum creatinine (mg/dL). Adequate coagulation function is defined as the international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; if the subject is receiving anticoagulation therapy, as long as the PT is within the proposed range of anticoagulation drugs; 7) Expected survival time ≥ 12 weeks; 8) Sign a written informed consent form and be able to comply with the visit and related procedures stipulated in the plan.
Key exclusion criteria (1 listed)
- 1) Refuse to participate; 2) Patients with esophageal squamous cell carcinoma who are diagnosed as stage IV or have surgical contraindications or refuse surgery; 3) Patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula; 4) Have previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody therapy, or any other antibodies targeting T cell costimulation or checkpoint pathways as specific targets or drug; 5) Participate in another interventional clinical study at the same time, unless participating in an observational (non-interventional) clinical study or in the follow-up phase of an interventional study; 6) Have received systemic systemic treatment with anti-tumor indications Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration; 7) Have used immunosuppressive drugs within 1 week before enrollment, excluding nasal spray, inhalation or other local glucocorticoids or physiological doses of systemic glucocorticoids (ie no more than 10mg/day prednisone Or equivalent doses of other glucocorticoids), or use hormones to prevent allergy to contrast agents; 8) Receive live attenuated vaccine within 4 weeks before the first dose of study treatment or plan to receive the live attenuated vaccine during the study period; Note: It is allowed to receive the inactivated virus vaccine for seasonal influenza by injection within 4 weeks before the first dose; but it is not allowed to receive Live attenuated influenza vaccine; 9) Major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment or expected major surgery during the study treatment period; 10) Prior to the first dose of study treatment, there was no recovery to the National Cancer Institute General Adverse Event Terminology version 5.0 (NCI CTCAE version 5.0) 0 or 1 toxicity (excluding hair loss, non-clinical) caused by previous anti-tumor therapy Significant and asymptomatic laboratory abnormalities); 11) Known active autoimmune disease and need symptomatic treatment or a history of the disease within the past 2 years (Vitiligo, psoriasis, hair loss or Grave's disease that does not require systemic treatment within the past 2 years, only need Patients with hypothyroidism under thyroid hormone replacement therapy and type I diabetes who only require insulin replacement therapy can be included in the group); 12) Known history of primary immunodeficiency; 13) Known to have active tuberculosis; 14) Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 15) Known to be allergic to any monoclonal antibody or chemotherapeutic drug (paclitaxel, cisplatin) preparations or excipient ingredients; 16) People with known HIV infection (HIV antibody positive); 17) Any arterial thromboembolic events, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack occurred within 6 months before being selected for treatment; 18) Significant malnutrition, such as intravenous supplementation of nutrient solutions; unless the malnutrition is corrected more than 4 weeks before the first dose of study treatment; 19) History of bowel obstruction or the following diseases: inflammatory bowel disease or extensive bowel resection (partial colectomy or extensive small bowel resection, complicated by chronic diarrhea), Crohn's disease, ulcerative colitis; 20) Known to have acute or chronic active hepatitis B (HBsAg positive and HBV DNA viral load ≥103 copies/mL or >200IU/ml) or acute or chronic active hepatitis C HCV antibody positive and HCV RNA Positive); 21) Suffer from interstitial lung disease that requires steroid therapy; 22) Female patients who are pregnant or breastfeeding; 23) Other acute or chronic diseases, mental illnesses, or abnormal laboratory test values that may cause the following results: increase the risk related to study participation or study drug administration, or interfere with the interpretation of the study results, and the patients shall be treated according to the judgment of the investigator Listed as not eligible to participate in this study.
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 |
|---|---|---|
| Sintilimab + chemotherapyBiological : Sintilimab 100mg: 10ml Method of administration: 200mg IV D1 Q3W. Drug: Cisplatin Injection Specification: 75mg/m2, IV D1 Q3W. Drug: Albumin Paclitaxel Injection specifications: 260mg/m2, IV D1 Q3W. | Drug | Arm 1 |
Primary outcome
Pathologic complete remission (PCR)
Time frame: 4 weeks after surgery
Primary tumor or lymph node surgery specimen pathological examination without residual tumor cell
2 secondary outcomes
Objective Response Rate (ORR)
Time frame: 4 weeks after surgery
Radiographic response
Time frame: From date of treatment allocation and during treatment period up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- Results publication: PubMed 34790369Huang B, Shi H, Gong X, Yu J, Xiao C, Zhou B, Liang Z, Li X. Comparison of efficacy and safety between pembrolizumab combined with chemotherapy and simple chemotherapy in neoadjuvant therapy for esophageal squamous cell carcinoma. J Gastrointest Oncol. 2021 Oct;12(5):2013-2021. doi: 10.21037/jgo-21-610.
- Results publication: PubMed 28314688Kudo T, Hamamoto Y, Kato K, Ura T, Kojima T, Tsushima T, Hironaka S, Hara H, Satoh T, Iwasa S, Muro K, Yasui H, Minashi K, Yamaguchi K, Ohtsu A, Doki Y, Kitagawa Y. Nivolumab treatment for oesophageal squamous-cell carcinoma: an open-label, multicentre, phase 2 trial. Lancet Oncol. 2017 May;18(5):631-639. doi: 10.1016/S1470-2045(17)30181-X. Epub 2017 Mar 15.
- Results publication: PubMed 33026938Kojima T, Shah MA, Muro K, Francois E, Adenis A, Hsu CH, Doi T, Moriwaki T, Kim SB, Lee SH, Bennouna J, Kato K, Shen L, Enzinger P, Qin SK, Ferreira P, Chen J, Girotto G, de la Fouchardiere C, Senellart H, Al-Rajabi R, Lordick F, Wang R, Suryawanshi S, Bhagia P, Kang SP, Metges JP; KEYNOTE-181 Investigators. Randomized Phase III KEYNOTE-181 Study of Pembrolizumab Versus Chemotherapy in Advanced Esophageal Cancer. J Clin Oncol. 2020 Dec 10;38(35):4138-4148. doi: 10.1200/JCO.20.01888. Epub 2020 Oct 7.
- Results publication: PubMed 33504550van den Ende T, de Clercq NC, van Berge Henegouwen MI, Gisbertz SS, Geijsen ED, Verhoeven RHA, Meijer SL, Schokker S, Dings MPG, Bergman JJGHM, Haj Mohammad N, Ruurda JP, van Hillegersberg R, Mook S, Nieuwdorp M, de Gruijl TD, Soeratram TTD, Ylstra B, van Grieken NCT, Bijlsma MF, Hulshof MCCM, van Laarhoven HWM. Neoadjuvant Chemoradiotherapy Combined with Atezolizumab for Resectable Esophageal Adenocarcinoma: A Single-arm Phase II Feasibility Trial (PERFECT). Clin Cancer Res. 2021 Jun 15;27(12):3351-3359. doi: 10.1158/1078-0432.CCR-20-4443. Epub 2021 Jan 27.
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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. This study is not recruiting at the moment.
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 Sintilimab + chemotherapy in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Soochow 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Zhao (86-0512-67972216, zhaojia0327@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete remission (PCR) (time frame: 4 weeks after surgery). 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 NCT05174325, 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 30 Dec 2021.