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

NCT05049681 | Unknown Phase 3

• 1 other identifier: SHR-1210-EC020
• Study Type: interventional
• Target: 234
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival(OS)

  the time from Randomization until death from any reason

  up to 2 year

Secondary Outcomes (7)

• Progression-free Survival (PFS)

  up to 2 year

• Objective Response Rate (ORR)

  up to 1 year

• Disease Control Rate (DCR)

  up to 1 year

• Duration of response（DOR）

  up to 2 year

• Time to response（TTP）

  up to 1 year

Study Arms (2)

SHR-1210（Camrelizumab）+Apatinib

EXPERIMENTAL

Apatinib 250mg, q.d.po; SHR-1210（Camrelizumab） 200 mg，Intravenous injection,q2W ,A course of treatment need 28 days.

Drug: Camrelizumab; Drug: Apatinib

SHR-1210（Camrelizumab）

ACTIVE COMPARATOR

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

Drug: Camrelizumab

Interventions

Camrelizumab DRUG

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

Also known as: SHR-1210

SHR-1210（Camrelizumab）; SHR-1210（Camrelizumab）+Apatinib

Apatinib DRUG

Apatinib 250mg, q.d.po

SHR-1210（Camrelizumab）+Apatinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Feng Wang: lead

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

camrelizumab; apatinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Feng Wang

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Wang

CONTACT

13938244776; zzuwangfeng@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 20, 2021
• Study Start: December 5, 2021
• Primary Completion: December 20, 2022
• Study Completion: June 30, 2023
• Last Updated: September 20, 2021

Record last verified: 2021-09