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Esophageal CancerPhase 3NCT05049681

Study of Anti-PD-1 Antibody SHR-1210 Plus Apatinib vs SHR-1210 as Second-Line Treatment of Advanced Esophageal Squamous Cell

A Phase 3 study testing Camrelizumab and Apatinib in people with Esophageal Cancer, run by Feng Wang.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 plus apatinib versus SHR-1210 as second-line treatment of advanced esophageal squamous cell. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Esophageal Cancer
What is being tested?
Camrelizumab and Apatinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
234 participants
Where
No sites listed yet
Study dates
5 Dec 2021to 30 Jun 2023
Phase
Phase 3
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged 18-75 years, males or females;
  • Histologically or cytologically confirmed as ESCC, locally advanced and unresectable, with local recurrence (local lymph node metastases) or distant metastases;
  • Having progressed or being intolerant to first-line systemic chemotherapy (including chemotherapy based on cisplatin, taxol or fluorouracil). Patients are also eligible if they progress after maintenance treatment following the first-line chemotherapy, or if patients with postoperative recurrence or metastasis progress after concurrent radiochemotherapy. As for the radical concurrent chemoradiotherapy, neoadjuvant/adjuvant treatment (chemotherapy or radiochemotherapy), if patients progress during the treatment or within six months after treatment, it is considered as a failure of first-line treatment;
  • According to the Response Evaluation Criteria In Solid Tumour (RECIST 1.1), there is at least one measurable lesion, which has not received any local treatment, such as radiotherapy (if the lesion within the region of the previous radiotherapy is confirmed to progress and satisfies RECIST1.1, it can be also selected as the target lesion) ;
  • Tissue samples should be provided for biomarker analysis. The newly harvested tissues are preferred. If the newly harvested tissues are not available, 5-8 archival paraffin sections (5 um thick) can be provided;
  • ECOG: 0~1;
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  • Expected survival time ≥ 12 weeks;
  • Adequate function of major organs defined as:(1) Routine blood test: a. HB ≥ 90 g/L; b. ANC ≥ 1.5 × 109/L; c. PLT ≥ 80 × 109/L;(2) Biochemical test: a. ALB ≥ 30 g/L; b. ALT and AST ≤ 2.5 ULN; if there is no liver metastasis, ALT and AST ≤ 5 ULN; c. TBIL ≤ 1.5ULN; d. Plasma Cr ≤ 1.5 ULN or creatinine clearance rate (CCr) ≥ 60 mL/min;
  • Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%).
  • Women of childbearing age should consent to take contraception measures during the study period and within 6 months after the end of the study (eg., intrauterine device, oral contraceptive pills or condoms). The subjects must be negative for the serum or urine pregnancy test within 7 days before the recruitment. The female subjects must be non-lactating women. Males should consent to take contraception measures during the study period and within 6 months after the end of the study;
  • All subjects are recruited on a voluntary basis and sign the informed consent. They are required to be compliant with the study and cooperative with the follow-up.

Who cannot join

  • Patients who have any active autoimmune diseases or a past history of autoimmune diseases (including but not limited to the following: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, and hyperthyroidism; leukoderma. Subjects with fully remitted childhood asthma and no need for any intervention during adulthood can be included; those still having the need for bronchodilators for medical intervention cannot be included);
  • Patients who are currently on immunosuppressors or systemic hormone therapy for immunosuppressive purposes (dose > 10 mg/day, prednisone or other hormones with equivalent efficacy), and continue taking them within 2 weeks before recruitment;
  • ESCC patients with active bleeding in primary lesions;
  • ESCC patients in whom the primary lesions are not surgically resected and are not shrunken in size after radiotherapy;
  • Patients who have received treatment with VEGFR inhibitors, such as sorafenib, sunitinib, and apatinib;
  • Any of the following conditions that will interfere with oral medications: unable to swallow, having received gastroenterectomy, chronic diarrhea and intestinal obstruction;
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  • Brain metastasis or brain metastases that have disappeared in less than 3 months;
  • Patients who have any severe and/or uncontrolled diseases, including: poor blood pressure control (systolic pressure ≥ 150 mmHg or diastolic pressure ≥ 100 mmHg); having myocardial ischemia or myocardial infarction and arrhythmia of Grade 1 and above (including QT interval ≥ 480 ms) and cardiac insufficiency of Grade 1; active or uncontrollable severe infection; liver diseases, such as decompensated liver failure, active hepatitis B (HBV-DNA ≥ 104 copy number/mL or 2000 IU/mL) or hepatitis C (positive for anti-HCV antibodies, and HCV-RNA higher than the lower limit of detection with the analytical method); routine urine test indicates urine protein ≥++ and confirms that the 24-hour urinary protein quantification>1.0 g;
  • Patients whose wounds or bone fractures remain unhealed for a long period of time;
  • Pneumorrhagia > NCI-CTC AE Grade1 within four weeks before recruitment; bleeding at other positions >NCI-CTC AE Grade 2 within four weeks before recruitment; having a bleeding tendency (eg., active peptic ulcer) or currently receiving thrombolytic or anticoagulant therapy, such as warfarin, heparin, or their analogs;
  • Patients who have experienced arterial/venous thrombotic events within six months, such as cerebrovascular accidents (including transient ischemic attack), deep venous thrombosis and pulmonary embolism;
  • The invasion of important blood vessels by the tumour or a high probability of the invasion of important blood vessels by the tumor that may lead to lethal hemorrhage in the study period ahead, as judged by the investigator according to the radiological examination;
  • Pregnancy or lactation;
  • Patients who have a history of other malignancies in the past five years (except for the cured basal cell carcinoma and cervical carcinoma in situ);
  • Patients who have a history of psychotropic drug abuse and unable to quit or having mental disorders;
  • Patients who have participated in other clinical trials of drugs in the past four weeks;
  • Patients who have concomitant diseases that may severely impair the safety of patients or make the patients unable to complete the study, as judged by the investigator;
  • Other patients who are considered inappropriate for participation by the investigator.

Trial locations and contacts

No sites are listed yet.

Feng Wang contact

13938244776

zzuwangfeng@zzu.edu.cn

About this study

Official title: Anti-PD-1 Antibody SHR-1210 Combined With Apatinib Versus SHR-1210 in the Second-line Treatment of Advanced Esophageal Squamous Cell Carcinoma：A Multicentre，Randomized， Open Label，Phase 3 Study

The purpose of this study is to observe and evaluate the efficacy and safety of Anti-PD-1 antibody SHR-1210 plus apatinib versus SHR-1210 as second-line treatment of advanced esophageal squamous cell.

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. Recently the study of KEYNOTE181, ATTRACTION-3 and ESCORT had confirmed that PD-1 single drug in the second-line treatment of esophageal cancer is better than the previous traditional chemotherapy, and has become a new standard treatment. In order to further improve the therapeutic efficacy and prognosis of advanced esophageal squamous cell carcinoma, we designed this phase III clinical study to compare the efficacy and safety of shr-1210 combined with apatinib and shr-1210 in the second-line treatment of esophageal squamous cell carcinoma.

Being tested
Camrelizumab, Apatinib
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • CamrelizumabDrug

    Also called SHR-1210

    SHR-1210（Camrelizumab） 200 mg，Intravenous injection， q2W ，A course of treatment need 28 days.

  • ApatinibDrug

    Apatinib 250mg, q.d.po

Study groups in NCT05049681
Study groupRoleWhat they receive
SHR-1210（Camrelizumab）+ApatinibExperimentalApatinib 250mg, q.d.po; SHR-1210（Camrelizumab） 200 mg，Intravenous injection,q2W ,A course of treatment need 28 days.
Receives: Drug: Camrelizumab; Drug: Apatinib
SHR-1210（Camrelizumab）Active comparatorSHR-1210（Camrelizumab） 200 mg，Intravenous injection. q2W ,A course of treatment need 28 days.
Receives: Drug: Camrelizumab

What is being measured

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

  1. Overall survival(OS)

    the time from Randomization until death from any reason

    Measured: up to 2 year

Secondary outcomes (7)

  1. Progression-free Survival (PFS)

    the time from Randomization to the first disease progression or death from any cause

    Measured: up to 2 year

  2. Objective Response Rate (ORR)

    the proportion of patients with complete response or partial response determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: up to 1 year

  3. Disease Control Rate (DCR)

    the proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD)

    Measured: up to 1 year

  4. Duration of response（DOR）

    the time from the first response date to the first disease progression or death date

    Measured: up to 2 year

  5. Time to response（TTP）

    the time from treatment to first confirmed tumour response

    Measured: up to 1 year

  6. 6-, 9- and 12-month OS rates

    overall survival rates at 6-, 9- and 12-month

    Measured: up to 1 year

  7. adverse events(Safety)

    adverse events

    Measured: up to 2 year

Timeline

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

  1. First posted20 Sep 2021
  2. Study start5 Dec 2021 (estimated)
  3. Primary completion20 Dec 2022 (estimated)
  4. Study completion30 Jun 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
234 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05049681
Sponsor's protocol ID
SHR-1210-EC020
Status last verified
Sep 2021
First submitted
13 Sep 2021
Last updated
20 Sep 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Camrelizumab and Apatinib in people with Esophageal Cancer, run by Feng Wang.

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 11 inclusion and 18 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 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 (13938244776, zzuwangfeng@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival(OS) (time frame: up to 2 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 NCT05049681.

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 20 Sep 2021.

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