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Esophageal Squamous Cell CarcinomaPhase 2NCT03766178

Study of Anti-PD-1 Antibody SHR-1210 Plus Nimotuzumab in the Treatment of Advanced Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Nimotuzumab + SHR-1210 in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to observe and evaluate the efficacy and safety of anti-PD-1 antibody SHR-1210 combined with nimotuzumab as second-line therapy in patients with advanced cancerous esophageal squamous cell carcinoma. 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?
Nimotuzumab + SHR-1210
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteChina
Study dates
Sep 2021to Sep 2023
Phase
Phase 2
Are there results?
None posted in the registry

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

  • 18~75 years, both men and women.
  • Pathologically (histologically or cytologically) confirmed diagnosis of esophageal squamous cell carcinoma (ESCC)， and locally advanced unresectable, local recurrence or distant metastasis.
  • Patients undergoing first-line systemic chemotherapy (which may include platinum, lavender or fluorouracil) progression or intolerance (progress in maintenance therapy after first-line chemotherapy can also be included). Synchronous chemoradiotherapy for postoperative recurrence or metastasis is considered as first-line treatment; For radical concurrent chemoradiotherapy, neoadjuvant/adjuvant therapy (chemotherapy or chemoradiotherapy), if disease progression occurs during treatment or within 6 months after stopping treatment, Count it as a first-line treatment failure.
  • At least one measurable/evaluable lesion by RECIST v1.1. And the measurable lesions should not have received local treatment such as radiotherapy (The lesion located in the previous radiotherapy area, if confirmed to progress, and meets the RECIST 1.1 standard, can also be used as a target lesion).
  • EGFR immunohistochemistry or FISH detection was positive in tumor tissue samples.
  • Tissue samples shall be provided for biomarker analysis, preferably newly acquired tissues, and patients who are unable to provide newly acquired tissues may provide 5-8 pieces of 5um thick paraffin sections that are archived and preserved.
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  • Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
  • Life expectancy of ≥ 12 weeks.
  • The main organs function normally, that is, the following criteria are met:
  • Blood routine examination:
  • HB≥90g/L;
  • ANC ≥ 1.5 × 109 / L;
  • PLT ≥ 80 × 109 / L. (2) Biochemical examination:
  • ALB ≥ 30g / L; b. ALT and AST ≤ 2.5ULN; if there is liver metastasis, ALT and AST ≤ 5ULN; c. TBIL ≤ 1.5ULN; d. plasma Cr ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min. 10. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF)≥ normal low limit (50%).
  • 11. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months of the end of the study; the serum or urine pregnancy test is negative within 7 days prior to study enrollment, and Must be non-lactating; males should agree to use contraceptives during the study period and within 6 months of the end of the study period.
  • 12. Subjects voluntarily joined the study, signed informed consent, and were well-adhered to follow-u.

Who cannot join

  • The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, thyroid Hyperfunction; patients with vitiligo; complete remission of asthma in childhood, can be included without any intervention after adult; asthma patients who require bronchodilators for medical intervention cannot be included).
  • The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppression purposes (dose >10 mg/day of prednisone or other therapeutic hormones) and continues to be used within 2 weeks prior to enrollment.
  • Patients who received EGFR monoclonal antibody or EGFR tyrosine kinase inhibitor;
  • Patients who received other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1;
  • Patients with brain metastases with symptoms or symptom control for less than 3 months;
  • Patients with any severe and/or uncontrolled diseases, including patients with unsatisfactory blood pressure control (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg); patients with grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QT interval ≥ 480ms) and grade I cardiac insufficiency; active or uncontrolled severe infection; liver disease such as decompensated liver disease, active hepatitis B (HBV-DNA ≥ 104 copy number / ml or 2000 IU / ml) Or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method);
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  • Imaging studies have shown that the tumor has invaded the important vascular circumference or that the patient is likely to invade the important;
  • Pregnant or lactating women.
  • Patients with other malignant tumors within 5 years（Except for skin basal cell carcinoma and cervical carcinoma in situ that have been cured).
  • Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder.
  • Patients who have participated in other drug clinical trials within four weeks.
  • According to the investigator's judgment, the patients with concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study.
  • Researchers believe that it is not suitable for inclusion. -

Trial locations and contacts

1 site in 1 country.

Feng Wang, Doctor contact

13938244776

fengw010@163.com

China1 site

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: A Single-arm, Open Phase II Clinical Trial of Anti-PD-1 Antibody SHR-1210 Combined With Nimotuzumab as Second-line Treatment of Advanced Esophageal Squamous Cell Carcinoma

The purpose of this study is to observe and evaluate the efficacy and safety of anti-PD-1 antibody SHR-1210 combined with nimotuzumab as second-line therapy in patients with advanced cancerous esophageal squamous cell carcinoma.

Read the detailed description

The incidence of esophageal cancer is ranked seventh in the world, and the mortality rate ranks sixth in the world. At present, the first-line treatment of advanced esophageal cancer is mainly based on the combination of paclitaxel, cisplatin and fluorouracil. After the failure of first-line treatment, there is no standard second-line treatment. The investigators designed a single-arm, open phase II clinical trial of anti-PD-1 antibody SHR-1210 combined with nimotuzumab as second-line therapy in patients with advanced cancerous esophageal squamous cell carcinoma.

Being tested
Nimotuzumab + SHR-1210
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.

  • Nimotuzumab + SHR-1210Drug

    SHR-1210: 200 mg/time, intravenous injection, q2W continuous medication, a course of treatment needs 28 days. The cumulative longest medication period is 2 years.

    Nimotuzumab: 200 mg/time, intravenous injection, administered on the 1st and 8th days of each cycle, every 2 weeks is one cycle.

Study groups in NCT03766178
Study groupRoleWhat they receive
Nimotuzumab + SHR-1210ExperimentalNimotuzumab + SHR-1210
Receives: Drug: Nimotuzumab + SHR-1210

What is being measured

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

  1. Objective Response Rate (ORR)

    From date of randomization until the date of death from any cause

    Measured: up to 1 year

Secondary outcomes (7)

  1. Disease Control Rate (DCR)

    Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD)

    Measured: up to 1 year

  2. Progression-free Survival (PFS)

    From date of randomization until the date of first documented progression or date of death from any cause

    Measured: up to 2 year

  3. Duration of response (DOR)

    Refers to the time when the tumor is first evaluated as CR or PR until the first assessment is PD (Progressive Disease) or any cause of death.

    Measured: up to 2 year

  4. Time to response (TTR)

    Measured: up to 1 year

  5. Overall survival(OS)

    From date of randomization until the date of death from any cause

    Measured: up to 2 year

  6. 9-month survival rate

    Measured: up to 9 month

  7. 12-month survival rate

    Measured: up to 12 month

Timeline

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

  1. First posted6 Dec 2018
  2. Study startSep 2021 (estimated)
  3. Primary completionDec 2022 (estimated)
  4. Study completionSep 2023 (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
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03766178
Sponsor's protocol ID
FQX-002
Status last verified
Jul 2021
First submitted
4 Dec 2018
Last updated
7 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xia J, Meng X, Jiang G, Hong Y, Ji Y, Wang C, Yang X, Meng Y, Zhang W, Luo Z, Cui D, Wang J, Shan Z, Guan L, Lu Y, Yang X, Ren C, Meng X, Wang H, Shen L, Zhang Y, Kou Z, Lu T, Fan Q, Quante M, Zhao T, Li S, Wang F. Camrelizumab plus nimotuzumab as second-line therapy for advanced esophageal squamous cell carcinoma: a multicenter phase II study. J Immunother Cancer. 2026 Sep 8;14(9):e015887. doi: 10.1136/jitc-2026-015887.

    PubMed 42711069

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nimotuzumab + SHR-1210 in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou 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 16 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 7 Jul 2021. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Feng Wang, Doctor (13938244776, fengw010@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: up to 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 NCT03766178, 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 7 Jul 2021.

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