Adebrelimab in Combination With Apatinib and Chemotherapy/Chemoradiotherapy in Immuno-experienced Second-line ESCC.

NCT06464614 | Not Yet Recruiting Phase 2

• 1 other identifier: ADE-ESCC-02
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the efficacy and safety of adebrelimab in combination with apatinib mesylate and chemoradiotherapy in immuno-experienced second-line esophageal squamous cell carcinoma (with symptomatic dysphagia or oligometastatic disease)，and to evaluate the efficacy and safety of adebrelimab in combination with apatinib mesylate and chemoradiotherapy in immuno-experienced second-line esophageal squamous cell carcinoma (without symptomatic dysphagia or oligometastatic disease).

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival，PFS

  Time from randomization to patient's tumor progression or death

  9 months

Secondary Outcomes (7)

• Objective Response Rate，ORR

  1 year

• Overall survival,OS

  1 year

• Duration of Response,DoR

  1 year

• Disease control rate,DCR

  1 year

• Time to response

  1 year

Study Arms (2)

Adebrelimab＋Apatinib＋Radiotherapy＋Investigator chosen chemotherapy (ICC)

EXPERIMENTAL

Adebrelimab（1200mg，d1 q3w, continuous medication until disease progression, intolerable toxicity, or withdrawal due to other reasons），Apatinib (250mg，d1-21，q3w), Radiotherapy， Investigator chosen chemotherapy (ICC)

Drug: Adebrelimab; Drug: Apatinib; Drug: Investigator chosen chemotherapy (ICC); Radiation: Radiotherapy

Adebrelimab＋Apatinib＋Investigator chosen chemotherapy (ICC)

EXPERIMENTAL

Adebrelimab（1200mg，d1 q3w, continuous medication until disease progression, intolerable toxicity, or withdrawal due to other reasons），Apatinib (250mg，d1-21，q3w), Investigator chosen chemotherapy (ICC)

Drug: Adebrelimab; Drug: Apatinib; Drug: Investigator chosen chemotherapy (ICC)

Interventions

Adebrelimab DRUG

Adebrelimab 1200mg，d1，q3w, until disease progression or unacceptable toxicity

Also known as: SHR-1316

Adebrelimab＋Apatinib＋Investigator chosen chemotherapy (ICC); Adebrelimab＋Apatinib＋Radiotherapy＋Investigator chosen chemotherapy (ICC)

Apatinib DRUG

Apatinib 250mg，d1-21，q3w, until disease progression or unacceptable toxicity

Also known as: Apatinib capsule

Adebrelimab＋Apatinib＋Investigator chosen chemotherapy (ICC); Adebrelimab＋Apatinib＋Radiotherapy＋Investigator chosen chemotherapy (ICC)

Investigator chosen chemotherapy (ICC) DRUG

Nab-paclitaxel: 125mg/m2 intravenously, D1, D8, q3w, 4-6 cycles;Intravenous infusion of 100 mg, D1, qw is used at the same time as radiotherapy. Ilinotecan: 125mg/m2 intravenously, D1, D8, q3w, 4-6 cycles; Capecitabine, 625 mg/m2 orally, d1-14, q3w; continued until disease progression, intolerable toxicity, or withdrawal due to other reasons; when synchronized with radiotherapy, 625mg/m2, bid, oral, d1-5, qw.

Also known as: Albumin-paclitaxel

Adebrelimab＋Apatinib＋Investigator chosen chemotherapy (ICC); Adebrelimab＋Apatinib＋Radiotherapy＋Investigator chosen chemotherapy (ICC)

Radiotherapy RADIATION

Radiotherapy mode: IMRT for the primary lesion and SBRT for the metastasis; If the patient has symptoms of dysphagia, the radiation dose is 1.8 Gy×28 F or 2 Gy×25 F, d1-5 5 times a week; If oligometastatic lesions occur in the body: the radiation dose is 8 Gy×5F, d1-5; If oligometastatic lesions occur in the brain, the radiation dose is 7 Gy×5F, d1-5.

Adebrelimab＋Apatinib＋Radiotherapy＋Investigator chosen chemotherapy (ICC)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 18-75 years old, male or female; 2. Esophageal squamous cell carcinoma confirmed by histology or cytology; 3. Patients who have progressed or are intolerant to first-line chemotherapy combined with immunotherapy (chemotherapy regimen can include platinum, purple shirt or fluorouracil as the basis, etc.) (progression of maintenance therapy after first-line chemotherapy combined with immunization can also be included).
• \. Cohort A: Subjects who have at least one of the following two conditions will be treated with adebelimab combined with apatinib mesylate and chemoradiotherapy;
• Symptomatic dysphagia, Mellow score ≥1 (Mellow score: 0 = able to eat all solid foods, 1 = only partially solid foods, 2 = able to eat soft foods, 3 = only able to drink liquids, 4 = complete dysphagia);
• Hypometastatic disease: Oligometastatic disease is considered when there are ≤ 3 metastases in the liver, lungs, retroperitoneal lymph nodes, adrenal glands, soft tissues, bones, or brain. In addition, after receiving a median of 18 weeks of systemic therapy, metastatic lesions are considered to be oligometastatic lesions at the time of restaging if they do not progress or only progress in size. If the number of lesions increases when restaged after systemic therapy, it is not considered oligometastatic disease.
• Cohort B: If the subjects do not have the above conditions, they will be treated with adebelimab in combination with apatinib mesylate and chemotherapy; 5. Have at least one measurable lesion according to the Efficacy Evaluation Criteria in Solid Tumors (RECIST 1.1); 6.ECOG：0～1； 7. Expected survival≥12 weeks; 8. The blood routine and biochemical indexes of the subjects within 7 days before enrollment meet the following criteria:
• a. Hemoglobin ≥90g/L, absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet ≥ 100×109/L (patients must not have received blood transfusion or growth factor support within 14 days of blood sample collection); b. ALT, AST ≤ 2.5 times the upper limit of normal (ULN); ALP ≤ 2.5 times ULN; c. Serum total bilirubin \< 1.5 times ULN (patients with Gilbert syndrome can be enrolled if total bilirubin \< 3 times ULN); d. Serum creatinine \< 1.5 times ULN or estimated glomerular filtration rate ≥60ml/min/1.73m2; e. Serum albumin≥30g/L; International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN, unless the patient is receiving anticoagulant therapy and the PT value is within the range of anticoagulant intended treatment; Activated partial thromboplastin time (APTT) ≤ 1.5 times ULN. 9. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ low limit of normal (50%).
• \. Females of childbearing potential should agree to use contraception (such as intrauterine device, contraceptive pills or condoms) during the study and for 6 months after the end of the study, have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating patients, and males should agree to use contraception during the study and for 6 months after the end of the study period; 11. No serious concomitant disease that makes the survival time \< 5 years; 12. Subjects voluntarily joined this study, signed the informed consent form, had good compliance, and cooperated with follow-up.

Sponsors & Collaborators

• The First Affiliated Hospital of Henan University of Science and Technology: lead

Study Sites (1)

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 470000, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

apatinib; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Ruinuo Jia

CONTACT

18537950766; jiaruinuo@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: July 15, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

CN (1)