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Esophageal Squamous Cell CarcinomaPhase 2NCT07312578

Nimotuzumab,Camrelizumab, and Neoadjuvant Chemotherapy（nCT） in the Treatment of Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Nimotuzumab, camrelizumab and Albumin paclitaxel in people with Esophageal Squamous Cell Carcinoma, run by Peking University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

We plan to conduct a single-center,prospective, Open Label, Randomized Controlled, Phase II Clinical Study of the Combination of Nimotuzumab,Camrelizumab, and Neoadjuvant Chemotherapy in the Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Nimotuzumab, camrelizumab and Albumin paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
1 Nov 2025to 1 Nov 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Sign the informed consent form; 2. Age range: 18-70 years old, both male and female are acceptable; 3. Esophageal squamous cell carcinoma patients diagnosed by histology or cytology; 4.ECOG：0～1； 5. Expected survival period ≥ 12 weeks; 6. Have not received any treatment for primary esophageal tumors in the past, including drug therapy, surgical treatment, and radiation therapy, etc; 7. Clinical staging: cT1-4a, N1-3, M0 (AJCC/UICC esophageal cancer staging (8th edition)), can be surgically resected; 8. Important organ functions meet the following requirements:
  • Absolute neutrophil count ≥ 1.5 × 109, platelet count ≥ 80 × 109, hemoglobin count ≥ 90g/L;
  • Total bilirubin level ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN (for patients with liver metastases, AST and ALT levels ≤ 5 times ULN);
  • Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 60 ml/min (Cockcroft Gault formula);
  • Serum albumin ≥ 28g/L;
  • Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%);
  • Pulmonary function: FEV1/FVC ≥ 70%, FEV1 ≥ 50% normal value, percentage of measured and predicted DLCO (lung diffusion function)>80%.
  • 9. Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, birth control pills, or condoms) during the study period and within 6 months after the end of the study; Within 7 days prior to enrollment in the study, the serum or urine pregnancy test must be negative and the patient must be non lactating; Men should agree to patients who must use contraception during the study period and within 6 months after the end of the study period.

Who cannot join

  • 1. Patients with any active autoimmune diseases or autoimmune diseases (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; asthma that has been completely relieved in childhood and does not require any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included); 2. The patient is currently using immunosuppressants or systemic hormone therapy to achieve immunosuppression (dose>10mg/day of prednisone or other therapeutic hormones), and has continued to use them within the 2 weeks prior to enrollment; 3. Previously received treatment with EGFR monoclonal antibodies or EGFR tyrosine kinase inhibitors; 4. Patients with any severe and/or uncontrolled illnesses, including:
  • Patients with poor blood pressure control (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100 mmHg); Suffering from grade I or above myocardial ischemia or infarction, arrhythmia (including QT interval ≥ 480ms), and grade I cardiac dysfunction;
  • Active or uncontrolled severe infections;
  • Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA ≥ 104 copies/ml or 2000IU/ml) or hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analytical method); 5. Patients whose imaging shows that the tumor has invaded important blood vessels or whose researchers have determined that the tumor is highly likely to invade important blood vessels and cause fatal bleeding during subsequent studies; 6. Pregnant or lactating women; Patients with other malignant tumors within 7.5 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ); 8. Patients with a history of abuse of psychotropic drugs who cannot be quit or those with mental disorders; 9. Patients who have participated in clinical trials of other drugs within the past four weeks; 10. Patients with accompanying diseases that pose a serious threat to patient safety or affect the completion of the study, as determined by the researchers; 11.Researchers believe that it is not suitable for inclusion.

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

  • Department of GI Oncology, Peking University Cancer Hospital,

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: A Prospective, Open Label, Randomized Controlled, Phase II Clinical Study of the Combination of Nimotuzumab,Camrelizumab, and Neoadjuvant Chemotherapy in the Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

We plan to conduct a single-center,prospective, Open Label, Randomized Controlled, Phase II Clinical Study of the Combination of Nimotuzumab,Camrelizumab, and Neoadjuvant Chemotherapy in the Treatment of Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

Read the detailed description

This study is a prospective, randomized controlled, open label clinical trial aimed at evaluating the efficacy and safety of the combination of nimotuzumab,camrelizumab, and neoadjuvant chemotherapy in patients with locally advanced resectable esophageal squamous cell carcinoma. The enrolled patients will receive neoadjuvant therapy (camrelizumab ±nimotuzumab+Albumin Paclitaxel+Cisplatin) and esophageal cancer radical surgery (performed within 4 weeks after the last drug treatment). This study includes screening period, treatment period, efficacy follow-up period, and survival follow-up period.

Being tested
Nimotuzumab, camrelizumab, Albumin paclitaxel, Cisplatin
Keywords
Nimotuzumab
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.

  • NimotuzumabDrug

    Nimotuzumab 400mg

  • camrelizumabDrug

    camrelizumab 200mg

  • Albumin paclitaxelDrug

    Albumin paclitaxel 125mg/m2

  • CisplatinDrug

    Cisplatin 75mg/m2

Study groups in NCT07312578
Study groupRoleWhat they receive
Nimotuzumab+Camrelizumab+Neoadjuvant chemotherapy（nCT）ExperimentalExperimental group: 1. Nimotuzumab: 400mg, Intravenous（iv）, day1（D1）, quaque week（QW）, 6 cycles; 2. Camrelizumab: 200mg, iv, D1, Q3W, 2 cycles; 3. Albumin paclitaxel: 125mg/m2, iv, D1, D8, Q3W, 2 cycles; 4. Cisplatin: 75mg/m2, iv, D1, Q3W, 2 cycles.
Receives: Drug: Nimotuzumab; Drug: camrelizumab; Drug: Albumin paclitaxel; Drug: Cisplatin
Camrelizumab+Neoadjuvant chemotherapy（nCT）Active comparator1. Camrelizumab: 200mg, iv, D1, Q3W, 2 cycles; 2. Albumin paclitaxel: 125mg/m2, iv, D1, D8, Q3W, 2 cycles; 3. Cisplatin: 75mg/m2, iv, D1, Q3W, 2 cycles.
Receives: Drug: camrelizumab; Drug: Albumin paclitaxel; Drug: Cisplatin

What is being measured

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

  1. Pathological complete response (pCR) rate

    Pathological complete response (pCR) rate

    Measured: up to 2 years

Secondary outcomes (1)

  1. Event-free survival （EFS）

    Event-free survival (assessed by the investigator per RECIST v1.1 criteria)

    Measured: from enrollment until firstly confirmed and recorded disease progression or death，assessed up to 3 years

Timeline

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

  1. First posted31 Dec 2025
  2. Study start1 Nov 2025
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 Nov 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
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07312578
Sponsor's protocol ID
IST-Nim-ESCC-26
Status last verified
Nov 2025
First submitted
17 Dec 2025
Last updated
31 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nimotuzumab, camrelizumab and Albumin paclitaxel in people with Esophageal Squamous Cell Carcinoma, run by Peking University 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 8 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 31 Dec 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) rate (time frame: up to 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 NCT07312578.

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 31 Dec 2025.

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