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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Watch and Wait for NeoAdjuvant Concurrent Radiochemotherapy Combined With Camrelizumab in Patients With Resectable ESCC

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)

Watch and Wait for NeoAdjuvant Concurrent Radiochemotherapy Combined With Camrelizumab in Patients With Resectable ESCC (NCT05507411) is a Phase 2 interventional studying Esophageal Squamous Cell Carcinoma, sponsored by Zhejiang Cancer Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Esophageal Squamous Cell Carcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Esophageal Squamous Cell Carcinoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Sign the willing to sign a consent form. Participants signed and dated written willing to sign a consent form. willing to sign a consent form 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; 2. Participant type and target disease characteristics Eastern Collaboration Group (ECOG) physical status score 0-1; diagnosed by tissue sample (biopsy-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; Who Should NOT Join This Trial: 1\) Medical condition There is locally advanced unresectable (regardless of stage) or metastatic disease. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. 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; 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: 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): i) 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;

Treatments Being Tested

RADIATION

Neoadjuvant Radiotherapy

41.4Gy/23F

DRUG

Neoadjuvant Chemotherapy

Paclitaxel for Injection (Albumin Bound): 50mg/m\^2 QW Carboplatin: AUC=2 QW

DRUG

Immunotherapy

Camrelizumab 200mg Q3W

Locations (3)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05507411), the sponsor (Zhejiang Cancer Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05507411 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05507411?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05507411?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05507411. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05507411. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.