Esophageal Squamous Cell CarcinomaPhase 2WATCHERNCT05507411
Watch and Wait for NeoAdjuvant Concurrent Radiochemotherapy Combined With Camrelizumab in Patients With Resectable ESCC
A Phase 2 study testing Neoadjuvant Radiotherapy, Neoadjuvant Chemotherapy and Immunotherapy in people with Esophageal Squamous Cell Carcinoma, run by Zhejiang Cancer Hospital at 3 sites in China.
Trial summary
To observe the 1-year disease-free survival rate (1-year PFS) of patients with resectable esophageal squamous cell carcinoma who received neoadjuvant chemoradiotherapy combined with camrelizumab and achieved clinical complete remission with watchful waiting strategy. 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?
- Neoadjuvant Radiotherapy, Neoadjuvant Chemotherapy and Immunotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesChina
- Study dates
- 3 Aug 2022to 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
- Sign the informed consent. Participants signed and dated written informed consent. Informed consent must be signed prior to any protocol-related procedures that are not part of the participant's routine medical care; Participants must be willing and able to comply with scheduled visits, treatment regimens, and laboratory tests;
- Participant type and target disease characteristics Eastern Collaboration Group (ECOG) physical status score 0-1; Histologically confirmed esophageal cancer with lesions located in the thoracic esophagus, AJCC/UICC esophageal cancer staging (eighth edition) clinical stage cT2-4aNanyM0, or cT1-3N+M0; Presence of measurable lesions according to RECIST criteria; Participants must have tumor tissue samples available for PD-L1 IHC testing; No major associated pathological conditions that increase the risk of surgery to unacceptable levels. Such as: esophageal perforation and active esophageal bleeding, obvious trachea, thoracic large blood vessel invasion; According to the surgeon's assessment, the total lung function can withstand the proposed esophageal cancer resection;
- Age and reproductive status Age ≥18 years old and ≤75 years old; Females of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity of 25 IU/L or equivalent for HCG) within 24 hours prior to initiation of study treatment; Women must be non-nursing;
Who cannot join
- 1) Medical condition There is locally advanced unresectable (regardless of stage) or metastatic disease.
- Participants with Grade ≥2 Peripheral Neuropathy; Participants with active, known or suspected autoimmune disease. Participants with type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin disorders that do not require systemic treatment (eg, vitiligo, psoriasis, or alopecia), or disorders that are not expected to recur in the absence of external stimuli are eligible to be enrolled; Participants requiring systemic therapy with glucocorticoids (>10 mg prednisone equivalent daily) or other immuno suppressive drugs within 14 days prior to treatment. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal hormone replacement therapy at >10 mg prednisone-equivalent daily are permitted; Known history of positive human immuno deficiency virus (HIV) test or known acquired immuno deficiency syndrome (AIDS); Participants with serious or uncontrolled medical illness; previous/concomitant therapy; Received chest radiotherapy, chemotherapy, immunotherapy, or surgery of the esophagus, esophagus and gastric junction, or stomach prior to the start of the trial.
- Patients with severe cardiovascular or pulmonary disease, interstitial pneumonia, or previous history of interstitial pneumonia; Patients with obvious esophageal ulcers, moderate pain in the chest and back, and esophageal perforation symptoms; Physical examination and laboratory test results
- Laboratory screening values must meet the following criteria (using CTCAE 4th edition):
- WBC < 2000/μL; ii) Neutrophils < 1500/μL; iii) Platelets < 100x103/μL; iv) Hemoglobin < 9.0 g/dL; v) Serum creatinine <1.5 x ULN or calculated creatinine clearance (CrCl) < 50 mL/min (using Cockcroft-Gault formula); vi) AST >3.0 x ULN; vii) ALT > 3.0 x ULN; viii) Total bilirubin >1.5 x ULN (except for Gilbert syndrome participants, who had total bilirubin < 3.0 x ULN); Participants had active hepatitis B (positive for hepatitis B surface antigen [HBsAg] or positive for hepatitis C virus (HCV) (positive for HCV RNA); i) Participants with previous or recovered HBV infection (defined as having hepatitis B core antibody [HBcAb] and no HBsAg) are eligible. HBV DNA from these patients must be obtained prior to treatment. Participants who are HBV carriers or require antiviral therapy are not eligible; ii) Participants positive for HCV antibodies are eligible only if PCR for HCV RNA is negative.; Active malignancy within the past 3 years, except for locally curable cancers that have been significantly cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast; Participants with serious or uncontrolled medical conditions; Allergic Reactions and Adverse Drug Reactions; History of allergic reactions or hypersensitivity reactions to study drug components Other exclusion criteria; Patients who do not understand trial requirements, or who may not comply with trial requirements; Active infection requiring systemic therapy 14 days prior to first dose Some obvious diseases that the researchers believe should be excluded from this study;
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yongling Ji contact
China3 sites, 3 recruiting
- Not yet recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)
Hanzhou, Zhejiang
Peng Ye, +86-18969976868
- Recruiting
Zhejiang Cancer Hospital
Hanzhou, Zhejiang
Qixun Chen, PhD, +86-13958108371, chenqixun64@163.com
Yongling Ji, PhD, +86-13958085251
- Not yet recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang
Weiyu Shen, +86-13805876129
About this study
Official title: Watch and Wait for NeoAdjuvant Concurrent Radiochemotherapy Combined With Camrelizumab in Patients With Resectable Esophageal Squamous Cell Carcinoma,A Prospective, Single-Center, Open Label,Phase II Cohort Study (WATCHER)
To observe the 1-year disease-free survival rate (1-year PFS) of patients with resectable esophageal squamous cell carcinoma who received neoadjuvant chemoradiotherapy combined with camrelizumab and achieved clinical complete remission with watchful waiting strategy.
Read the detailed description
This trial is a prospective, multicenter, randomized controlled phase II clinical study.
Eligible patients with thoracic esophageal squamous cell carcinoma in clinical stage cT2-4aNanyM0, or cT1-3N+M0. The patient received radiotherapy (41.4Gy/23F), chemotherapy (nab-paclitaxel combined with carboplatin), immunotherapy (Camrelizumab), and a combination of imaging, endoscopy and biopsy pathology was performed 4-6 weeks after the end of neoadjuvant therapy.
Evaluate (CRE1) to determine whether clinical complete resection (cCR) has been achieved. If clinical complete resection is not reached, patients will receive radical surgery; For subjects who have achieved clinical complete resection(cCR), they will be randomly divided into an operation group and an observational waiting group. After 14 weeks, the combined imaging, endoscopy and biopsy pathological evaluation (CRE2) was performed again to determine whether the clinical complete resection (CCR2) was reached. If the patient has local progression and can be resected, radical surgery will be performed; if there is distant progression, medical oncology treatment or supportive treatment will be performed; if clinical complete resection remains, continuous and close imaging, endoscopic and Biopsy pathology combined evaluation (CRE3-14). After achieving clinical complete resection, patients who continue to be followed up for observation or undergo radical surgery, if there is no contraindication to treatment, receive 14 cycles of Camrelizumab maintenance therapy. During follow-up stage, if the patient develops local progression and can be resected, radical surgery is performed; if distant progression occurs, medical oncology treatment or supportive treatment is performed; if clinical complete remission is still achieved, follow-up evaluation can be continued. Among them, the 1-year disease-free survival rate under the esophagus-sparing treatment strategy after achieving clinical complete remission was the main endpoint of the study.
To observe the disease-free survival(DFS), overall survival(OS), event-free survival(EFS), quality of life(QoL), failure mode and choice of post-failure treatment mode after neoadjuvant chemoradiotherapy combined with Camrelizumab therapy or after surgical resection. And, the pathological complete remission rate and the main pathological resection rate of the patients who underwent surgery.
The blood, stool and tissue samples of patients participating in the trial will be retained for future detection of relevant markers and related laboratory research.
Treatment safety and toxicity, including acute and chronic toxicity, will be evaluated on an ongoing basis during treatment and follow-up.
Any serious adverse drug reactions will be promptly reported to the hospital ethics committee.
The relationship between relevant markers and clinical outcomes will be analyzed.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Neoadjuvant Radiotherapy, Neoadjuvant Chemotherapy, Immunotherapy
- Keywords
- Esophageal Squamous Cell Carcinoma, NeoAdjuvant therapy, immunotherapy, Concurrent Radiochemotherapy, organ preservation
- 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.
Neoadjuvant RadiotherapyRadiation
41.4Gy/23F
Neoadjuvant ChemotherapyDrug
Paclitaxel for Injection (Albumin Bound): 50mg/m^2 QW Carboplatin: AUC=2 QW
ImmunotherapyDrug
Camrelizumab 200mg Q3W
| Study group | Role | What they receive |
|---|---|---|
| CCR-Watch and Wait | Other | Not described Receives: Radiation: Neoadjuvant Radiotherapy; Drug: Neoadjuvant Chemotherapy; Drug: Immunotherapy |
| CCR-Surgery | Other | Not described Receives: Radiation: Neoadjuvant Radiotherapy; Drug: Neoadjuvant Chemotherapy; Drug: Immunotherapy |
| Non-CCR | Other | Not described Receives: Radiation: Neoadjuvant Radiotherapy; Drug: Neoadjuvant Chemotherapy; Drug: Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year DFS of CCR-Watch and Wait group
Measured: 1 year
Secondary outcomes (7)
Overall Survival
Measured: 5 years
EFS
Measured: 5 years
cCR rate
Measured: 1 year
pCR rate
Measured: 1 year
MPR rate
Measured: 1 year
FACT-E
Quality of life
Measured: 5 years
EORTC QLQ-30
Quality of life
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start3 Aug 2022
- Primary completionApr 2024 (estimated)
- Study completionApr 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 Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Qixun Chen, Zhejiang Cancer Hospital
- Investigators
- Qixun Chen, Principal investigator, Zhejiang Cancer HospitalYongling Ji, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507411
- Sponsor's protocol ID
- WATCHER
- Acronym
- WATCHER
- Status last verified
- Aug 2022
- First submitted
- 12 Aug 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang W, Ye L, Li H, Chen W, Hong W, Mao W, Xu X. A narrative review on advances in neoadjuvant immunotherapy for esophageal cancer: Molecular biomarkers and future directions. Int J Cancer. 2025 Jan 1;156(1):20-33. doi: 10.1002/ijc.35153. Epub 2024 Sep 14.
PubMed 39276114
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Watch and Wait for NeoAdjuvant Concurrent Radiochemotherapy Combined With Camrelizumab in Patients With Resectable Esophageal Squamous Cell Carcinoma,A Prospective, Single-Center, Open Label,Phase II Cohort Study (WATCHER)
- ClinicalTrials.gov ID
- NCT05507411
- Acronym / sponsor ID
- WATCHER / WATCHER
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Esophageal Squamous Cell Carcinoma, NeoAdjuvant therapy, immunotherapy, Concurrent Radiochemotherapy, organ preservation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 19 Aug 2022 (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.
To observe the 1-year disease-free survival rate (1-year PFS) of patients with resectable esophageal squamous cell carcinoma who received neoadjuvant chemoradiotherapy combined with camrelizumab and achieved clinical complete remission with watchful waiting strategy.
Detailed description
This trial is a prospective, multicenter, randomized controlled phase II clinical study.
Eligible patients with thoracic esophageal squamous cell carcinoma in clinical stage cT2-4aNanyM0, or cT1-3N+M0. The patient received radiotherapy (41.4Gy/23F), chemotherapy (nab-paclitaxel combined with carboplatin), immunotherapy (Camrelizumab), and a combination of imaging, endoscopy and biopsy pathology was performed 4-6 weeks after the end of neoadjuvant therapy.
Evaluate (CRE1) to determine whether clinical complete resection (cCR) has been achieved. If clinical complete resection is not reached, patients will receive radical surgery; For subjects who have achieved clinical complete resection(cCR), they will be randomly divided into an operation group and an observational waiting group. After 14 weeks, the combined imaging, endoscopy and biopsy pathological evaluation (CRE2) was performed again to determine whether the clinical complete resection (CCR2) was reached. If the patient has local progression and can be resected, radical surgery will be performed; if there is distant progression, medical oncology treatment or supportive treatment will be performed; if clinical complete resection remains, continuous and close imaging, endoscopic and Biopsy pathology combined evaluation (CRE3-14). After achieving clinical complete resection, patients who continue to be followed up for observation or undergo radical surgery, if there is no contraindication to treatment, receive 14 cycles of Camrelizumab maintenance therapy. During follow-up stage, if the patient develops local progression and can be resected, radical surgery is performed; if distant progression occurs, medical oncology treatment or supportive treatment is performed; if clinical complete remission is still achieved, follow-up evaluation can be continued. Among them, the 1-year disease-free survival rate under the esophagus-sparing treatment strategy after achieving clinical complete remission was the main endpoint of the study.
To observe the disease-free survival(DFS), overall survival(OS), event-free survival(EFS), quality of life(QoL), failure mode and choice of post-failure treatment mode after neoadjuvant chemoradiotherapy combined with Camrelizumab therapy or after surgical resection. And, the pathological complete remission rate and the main pathological resection rate of the patients who underwent surgery.
The blood, stool and tissue samples of patients participating in the trial will be retained for future detection of relevant markers and related laboratory research.
Treatment safety and toxicity, including acute and chronic toxicity, will be evaluated on an ongoing basis during treatment and follow-up.
Any serious adverse drug reactions will be promptly reported to the hospital ethics committee.
The relationship between relevant markers and clinical outcomes will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CCR-Watch and Wait | Other | Radiation: Neoadjuvant Radiotherapy, Drug: Neoadjuvant Chemotherapy, Drug: Immunotherapy |
| CCR-Surgery | Other | Radiation: Neoadjuvant Radiotherapy, Drug: Neoadjuvant Chemotherapy, Drug: Immunotherapy |
| Non-CCR | Other | Radiation: Neoadjuvant Radiotherapy, Drug: Neoadjuvant Chemotherapy, Drug: Immunotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sign the informed consent. Participants signed and dated written informed consent. Informed consent must be signed prior to any protocol-related procedures that are not part of the participant's routine medical care; Participants must be willing and able to comply with scheduled visits, treatment regimens, and laboratory tests;
- Participant type and target disease characteristics Eastern Collaboration Group (ECOG) physical status score 0-1; Histologically confirmed esophageal cancer with lesions located in the thoracic esophagus, AJCC/UICC esophageal cancer staging (eighth edition) clinical stage cT2-4aNanyM0, or cT1-3N+M0; Presence of measurable lesions according to RECIST criteria; Participants must have tumor tissue samples available for PD-L1 IHC testing; No major associated pathological conditions that increase the risk of surgery to unacceptable levels. Such as: esophageal perforation and active esophageal bleeding, obvious trachea, thoracic large blood vessel invasion; According to the surgeon's assessment, the total lung function can withstand the proposed esophageal cancer resection;
- Age and reproductive status Age ≥18 years old and ≤75 years old; Females of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity of 25 IU/L or equivalent for HCG) within 24 hours prior to initiation of study treatment; Women must be non-nursing;
Key exclusion criteria (5 listed)
- 1) Medical condition There is locally advanced unresectable (regardless of stage) or metastatic disease.
- Participants with Grade ≥2 Peripheral Neuropathy; Participants with active, known or suspected autoimmune disease. Participants with type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin disorders that do not require systemic treatment (eg, vitiligo, psoriasis, or alopecia), or disorders that are not expected to recur in the absence of external stimuli are eligible to be enrolled; Participants requiring systemic therapy with glucocorticoids (>10 mg prednisone equivalent daily) or other immuno suppressive drugs within 14 days prior to treatment. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal hormone replacement therapy at >10 mg prednisone-equivalent daily are permitted; Known history of positive human immuno deficiency virus (HIV) test or known acquired immuno deficiency syndrome (AIDS); Participants with serious or uncontrolled medical illness; previous/concomitant therapy; Received chest radiotherapy, chemotherapy, immunotherapy, or surgery of the esophagus, esophagus and gastric junction, or stomach prior to the start of the trial.
- Patients with severe cardiovascular or pulmonary disease, interstitial pneumonia, or previous history of interstitial pneumonia; Patients with obvious esophageal ulcers, moderate pain in the chest and back, and esophageal perforation symptoms; Physical examination and laboratory test results
- WBC < 2000/μL; ii) Neutrophils < 1500/μL; iii) Platelets < 100x103/μL; iv) Hemoglobin < 9.0 g/dL; v) Serum creatinine <1.5 x ULN or calculated creatinine clearance (CrCl) < 50 mL/min (using Cockcroft-Gault formula); vi) AST >3.0 x ULN; vii) ALT > 3.0 x ULN; viii) Total bilirubin >1.5 x ULN (except for Gilbert syndrome participants, who had total bilirubin < 3.0 x ULN); Participants had active hepatitis B (positive for hepatitis B surface antigen [HBsAg] or positive for hepatitis C virus (HCV) (positive for HCV RNA); i) Participants with previous or recovered HBV infection (defined as having hepatitis B core antibody [HBcAb] and no HBsAg) are eligible. HBV DNA from these patients must be obtained prior to treatment. Participants who are HBV carriers or require antiviral therapy are not eligible; ii) Participants positive for HCV antibodies are eligible only if PCR for HCV RNA is negative.; Active malignancy within the past 3 years, except for locally curable cancers that have been significantly cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast; Participants with serious or uncontrolled medical conditions; Allergic Reactions and Adverse Drug Reactions; History of allergic reactions or hypersensitivity reactions to study drug components Other exclusion criteria; Patients who do not understand trial requirements, or who may not comply with trial requirements; Active infection requiring systemic therapy 14 days prior to first dose Some obvious diseases that the researchers believe should be excluded from 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 |
|---|---|---|
| Neoadjuvant Radiotherapy41.4Gy/23F | Radiation | CCR-Surgery, CCR-Watch and Wait, Non-CCR |
| Neoadjuvant ChemotherapyPaclitaxel for Injection (Albumin Bound): 50mg/m^2 QW Carboplatin: AUC=2 QW | Drug | CCR-Surgery, CCR-Watch and Wait, Non-CCR |
| ImmunotherapyCamrelizumab 200mg Q3W | Drug | CCR-Surgery, CCR-Watch and Wait, Non-CCR |
Primary outcome
1-year DFS of CCR-Watch and Wait group
Time frame: 1 year
7 secondary outcomes
Overall Survival
Time frame: 5 years
EFS
Time frame: 5 years
cCR rate
Time frame: 1 year
pCR rate
Time frame: 1 year
MPR rate
Time frame: 1 year
FACT-E
Time frame: 5 years
EORTC QLQ-30
Time frame: 5 years
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 19 Aug 2022.
- Derived from this study: PubMed 39276114Wang W, Ye L, Li H, Chen W, Hong W, Mao W, Xu X. A narrative review on advances in neoadjuvant immunotherapy for esophageal cancer: Molecular biomarkers and future directions. Int J Cancer. 2025 Jan 1;156(1):20-33. doi: 10.1002/ijc.35153. Epub 2024 Sep 14.
- Individual participant dataSharing planned: No
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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.
Yongling Ji contact
Qixun Chen principal investigator
Zhejiang Cancer Hospital
Yongling Ji principal investigator
Zhejiang Cancer Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant Radiotherapy, Neoadjuvant Chemotherapy and Immunotherapy in people with Esophageal Squamous Cell Carcinoma, run by Zhejiang Cancer Hospital at 3 sites 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 3 inclusion and 5 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 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qixun Chen (+86-13958108371, chenqixun64@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year DFS of CCR-Watch and Wait group (time frame: 1 year). 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 NCT05507411, 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 19 Aug 2022.