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Esophageal CancerPhase 2NCT06869226

A Multicenter Phase II Clinical Study of Neoadjuvant Use of Camrelizumab in Combination With Chemotherapy for Organ Preservation in Esophageal Cancer

A Phase 2 study testing Camrelizumab + Nab-paclitaxel + Cisplatin in people with Esophageal Cancer, run by Peking University Cancer Hospital & Institute at 1 site 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
Search all trials

Trial summary

This is a multicenter phase II clinical study to explore the efficacy, safety, and organ preservation feasibility of camrelizumab in combination with chemotherapy for resectable esophageal squamous carcinoma in patients with histologically and pathologically confirmed resectable esophageal squamous carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Cancer
What is being tested?
Camrelizumab + Nab-paclitaxel + Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
283 participants
Where
1 siteChina
Study dates
30 Apr 2025to 31 Dec 2029
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

  • Subjects voluntarily enrolled in this study, signed the informed consent form, had good compliance, and could cooperate with follow-up visits;
  • esophageal cancer diagnosed by histopathology; clinical staging of cT1b-cT2 N+ M0 or cT3, any N, M0 (according to AJCC 8th edition);
  • Age 18-75 years old, male or female;
  • ECOG PS 0-1;
  • measurable tumor lesions or non-measurable lesions that can be evaluated;
  • not having received any previous anti-tumor therapy for esophageal cancer, including radiotherapy, chemotherapy, surgery, etc;
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  • Normal or mildly to moderately abnormal lung function (VC%>60%, FEV1>1.2L, FEV1%>40%, DLco>40%) that can tolerate esophageal cancer resection;
  • No contraindications to surgery;
  • function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days): (1) Normal bone marrow reserve function with white blood cell (WBC) ≥3.0×109/L; neutrophil count (NEUT) ≥1.5×109/L, platelet count (PLT) ≥100×109/L, hemoglobin (Hb) ≥90g/L; (2) Normal renal function with serum creatinine (SCr) ≤1.5 times upper limit of normal (ULN) or creatinine clearance ≥60 ml/min (Cockcroft-Gault formula); (3) Normal liver function with total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); and an albumin transaminase (AST) or alanine transaminase (ALT) level ≤2.5 times the upper limit of normal (ULN); (4) Normal coagulation function with International Normalized Ratio (INR) ≤ 1.5 times the upper limit of normal (ULN) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times the upper limit of normal (ULN).
  • Patients with potential childbearing potential are required to use a medically approved contraceptive method (e.g., IUD, birth control pills, or condoms) during and for 6 months after the end of the study treatment period; must have had a negative serum HCG or urine HCG test for 72 h prior to study entry; and must not be breastfeeding.

Who cannot join

  • Presence of locally advanced unresectable (regardless of stage) or metastatic disease (stage IV);
  • Exclude patients with cervical segment esophageal cancer;
  • Previous history of allergy to monoclonal antibodies, any component of karelizumab, albumin-bound paclitaxel, carboplatin or other platinum drugs;
  • patients with moderate or greater chest and back pain and risk of esophageal perforation.
  • have received or are receiving any of the following treatments in the past: (1) any radiotherapy, chemotherapy, or other antineoplastic agents directed against the tumor; (2) Treatment with immunosuppressive drugs, or systemic hormonal drugs for immunosuppression (doses >10 mg/day prednisone or equivalent) within 2 weeks prior to first use of study drug; inhaled or topical steroids and adrenocorticotropic hormone replacement at doses >10 mg/day prednisone or equivalent are permissible in the absence of active autoimmune disease; (3) Received a live attenuated vaccine within 4 weeks prior to first use of study drug; (4) Major surgery or severe trauma within 4 weeks prior to first use of study drug;
  • Have any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism (may be considered for inclusion after hormone replacement therapy); patients with psoriasis or childhood asthma/allergies that have been in complete remission and do not require any interventions in adulthood may be considered for inclusion, but patients requiring bronchial Patients who require medical intervention with bronchodilators may not be included;
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  • a history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation or allogeneic bone marrow transplantation;
  • the presence of clinically uncontrolled cardiac conditions or diseases, including but not limited to, such as (1) NYHA class II or higher heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, and (4) clinically significant supraventricular or ventricular arrhythmia that is not clinically intervened with or remains poorly controlled after clinical intervention;
  • a serious infection (CTCAE grade 2) such as severe pneumonia requiring hospitalization, bacteremia, or infectious co-morbidities within 4 weeks prior to the first use of study drug; except for prophylactic antibiotic use if baseline chest imaging suggests the presence of active pulmonary inflammation, signs and symptoms of infection within 14 days prior to the first use of study drug, or the need for treatment with oral or intravenous antibiotics;
  • the presence of active tuberculosis infection by history or CT scan, or a history of active tuberculosis infection within 1 year prior to enrollment, or a history of active tuberculosis infection more than 1 year ago without regular treatment
  • Presence of active hepatitis B HBV DNA ≥ 2000 IU/mL or 104 copies/mL hepatitis C (hepatitis C antibody positive and HCV RNA above the lower detection limit of the analytical method);
  • other malignancies diagnosed within 5 years prior to first use of study drug, unless malignancies with a low risk of metastasis or risk of death (5-year survival > 90%), such as adequately treated basal cell carcinoma of the skin or squamous cell skin carcinoma or carcinoma of the cervix in situ, may be considered for enrollment
  • Pregnant or lactating females;
  • In the judgment of the investigator, there are other factors that may lead to forced termination of the study in the middle of the study, such as suffering from other serious illnesses (including psychiatric illnesses) that require comorbid treatment, alcoholism, drug abuse, family or social factors that may affect the safety of or compliance with the subject.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Peking University Cancer Hospital

    Beijing, 100142

    Luyan Shen, 15811408473, shenluyan@pku.edu.cn

    Recruiting

Other trials in China

About this study

This is a multicenter phase II clinical study to explore the efficacy, safety, and organ preservation feasibility of camrelizumab in combination with chemotherapy for resectable esophageal squamous carcinoma in patients with histologically and pathologically confirmed resectable esophageal squamous carcinoma.

Being tested
Camrelizumab + Nab-paclitaxel + Cisplatin
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Camrelizumab + Nab-paclitaxel + CisplatinDrug

    Three cycles of neoadjuvant therapy with camrelizumab (200 mg/dose D1, IV, Q3W)+Nab-paclitaxel(260 mg/m2 D1，IV，Q3W)+Cisplatin(75 mg/m2 D1，IV，Q3W); for patients with organ preservation intent entered into the watchful waiting strategy group and received radiotherapy (50.4 Gy/28 doses), with camrelizumab maintenance therapy for 4-12 weeks after the end of radiotherapy, and a total of up to one year of camrelizumab.

Study groups in NCT06869226
Study groupRoleWhat they receive
Camrelizumab+chemotherapyExperimentalNot described
Receives: Drug: Camrelizumab + Nab-paclitaxel + Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event-free survival (EFS)

    The length of time between signing the informed consent form and the occurrence of any of the following events: disease progression, disease recurrence, or death from any cause

    Measured: about 2 years

Secondary outcomes (5)

  1. Clinical complete remission (cCR) rate

    Defined as the proportion of subjects who achieved CR as assessed according to RECIST 1.1 and whose endoscopic biopsies were free of residual tumor;

    Measured: about 2 years

  2. Pathologic complete remission (pCR) rate

    Defined as no residual tumor cells after evaluation of the resected tumor tissue and regional lymph.

    Measured: about 2 years

  3. Progression-free survival (PFS) in subjects with organ preservation strategies

    From the time of dosing until tumor recurrence, including local recurrence or distant metastasis or death from any cause, based on imaging evaluation or tissue biopsy evidence, whichever occurs first;

    Measured: about 2 years

  4. Overall survival (OS) in subjects with organ preservation strategies

    Time from administration to death from any cause

    Measured: about 2 years

  5. Adverse Events (AE)

    Incidence and grade (including serious adverse events and immunization-related adverse events), as determined by NCI-CTCAE 5.0 criteria

    Measured: about 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2025
  2. Study start30 Apr 2025
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
283 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06869226
Sponsor's protocol ID
2024YJZ151
Status last verified
Mar 2025
First submitted
5 Mar 2025
Last updated
2 Oct 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab + Nab-paclitaxel + Cisplatin in people with Esophageal Cancer, run by Peking University Cancer Hospital & Institute at 1 site 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 10 inclusion and 14 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 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event-free survival (EFS) (time frame: about 2 years). 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 NCT06869226.

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 2 Oct 2025.

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