Watch and Wait for NeoAdjuvant Concurrent Radiochemotherapy Combined With Camrelizumab in Patients With Resectable ESCC
NCT ID: NCT05507411
Last Updated: 2022-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2022-08-03
2027-04-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CCR-Watch and Wait
Neoadjuvant Radiotherapy
41.4Gy/23F
Neoadjuvant Chemotherapy
Paclitaxel for Injection （Albumin Bound): 50mg/m\^2 QW Carboplatin: AUC=2 QW
Immunotherapy
Camrelizumab 200mg Q3W
CCR-Surgery
Neoadjuvant Radiotherapy
41.4Gy/23F
Neoadjuvant Chemotherapy
Paclitaxel for Injection （Albumin Bound): 50mg/m\^2 QW Carboplatin: AUC=2 QW
Immunotherapy
Camrelizumab 200mg Q3W
Non-CCR
Neoadjuvant Radiotherapy
41.4Gy/23F
Neoadjuvant Chemotherapy
Paclitaxel for Injection （Albumin Bound): 50mg/m\^2 QW Carboplatin: AUC=2 QW
Immunotherapy
Camrelizumab 200mg Q3W
Interventions
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Neoadjuvant Radiotherapy
41.4Gy/23F
Neoadjuvant Chemotherapy
Paclitaxel for Injection （Albumin Bound): 50mg/m\^2 QW Carboplatin: AUC=2 QW
Immunotherapy
Camrelizumab 200mg Q3W
Eligibility Criteria
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Inclusion Criteria
2. 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；
3. 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；
Exclusion Criteria
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):
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Zhejiang Cancer Hospital
OTHER
Responsible Party
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Qixun Chen
Director
Principal Investigators
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Qixun Chen
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Yongling Ji
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Cancer Hospital
Locations
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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
Countries
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Central Contacts
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Yongling Ji
Role: CONTACT
Facility Contacts
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Peng Ye
Role: primary
Yongling Ji, PhD
Role: backup
Weiyu Shen
Role: primary
References
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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.
Other Identifiers
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WATCHER
Identifier Type: -
Identifier Source: org_study_id
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