Watch and Wait for NeoAdjuvant Concurrent Radiochemotherapy Combined With Camrelizumab in Patients With Resectable ESCC
WATCHER
1 other identifier
interventional
100
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2022
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 3, 2022
CompletedFirst Submitted
Initial submission to the registry
August 12, 2022
CompletedFirst Posted
Study publicly available on registry
August 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
ExpectedAugust 19, 2022
August 1, 2022
1.7 years
August 12, 2022
August 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
1-year DFS of CCR-Watch and Wait group
1 year
Secondary Outcomes (7)
Overall Survival
5 years
EFS
5 years
cCR rate
1 year
pCR rate
1 year
MPR rate
1 year
- +2 more secondary outcomes
Study Arms (3)
CCR-Watch and Wait
OTHERCCR-Surgery
OTHERNon-CCR
OTHERInterventions
Paclitaxel for Injection （Albumin Bound): 50mg/m\^2 QW Carboplatin: AUC=2 QW
Eligibility Criteria
You may qualify if:
- 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；
You may not qualify if:
- \) 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):
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhejiang Cancer Hospitallead
- Jiangsu HengRui Medicine Co., Ltd.collaborator
Study Sites (3)
The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)
Hanzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hanzhou, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
Related Publications (1)
Al-Batran SE, Koch C. Neoadjuvant therapy for oesophageal cancer: refining the armamentarium. Lancet. 2024 Jul 6;404(10447):5-7. doi: 10.1016/S0140-6736(24)01084-5. Epub 2024 Jun 11. No abstract available.
PMID: 38876135DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qixun Chen
Zhejiang Cancer Hospital
- PRINCIPAL INVESTIGATOR
Yongling Ji
Zhejiang Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
August 12, 2022
First Posted
August 19, 2022
Study Start
August 3, 2022
Primary Completion
April 1, 2024
Study Completion (Estimated)
April 1, 2027
Last Updated
August 19, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share