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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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

+86-13958085251

China3 sites, 3 recruiting
  • The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)

    Hanzhou, Zhejiang

    Peng Ye, +86-18969976868

    Not yet recruiting
  • Zhejiang Cancer Hospital

    Hanzhou, Zhejiang

    Qixun Chen, PhD, +86-13958108371, chenqixun64@163.com

    Yongling Ji, PhD, +86-13958085251

    Recruiting
  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang

    Weiyu Shen, +86-13805876129

    Not yet recruiting

Other trials in China

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.

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 groups in NCT05507411
Study groupRoleWhat they receive
CCR-Watch and WaitOtherNot described
Receives: Radiation: Neoadjuvant Radiotherapy; Drug: Neoadjuvant Chemotherapy; Drug: Immunotherapy
CCR-SurgeryOtherNot described
Receives: Radiation: Neoadjuvant Radiotherapy; Drug: Neoadjuvant Chemotherapy; Drug: Immunotherapy
Non-CCROtherNot 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. 1-year DFS of CCR-Watch and Wait group

    Measured: 1 year

Secondary outcomes (7)
  1. Overall Survival

    Measured: 5 years

  2. EFS

    Measured: 5 years

  3. cCR rate

    Measured: 1 year

  4. pCR rate

    Measured: 1 year

  5. MPR rate

    Measured: 1 year

  6. FACT-E

    Quality of life

    Measured: 5 years

  7. 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.

  1. First posted19 Aug 2022
  2. Study start3 Aug 2022
  3. Primary completionApr 2024 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

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)
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

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.

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