Immunotherapy Plus Chemotherapy vs. Chemoradiotherapy for Thoracic Squamous Esophageal Carcinoma

NCT ID: NCT05821452

Last Updated: 2023-04-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-25
• Study Completion Date: 2026-05-30

Brief Summary

The investigators conducted a phase II, prospective, two-arm clinical study to explore the efficacy of Camrelizumab combined with chemotherapy versus chemoradiotherapy for conversion therapy of potentially resectable advanced esophageal squamous cell carcinoma. This study will provide more evidence for conversion treatment of initially unresectable locally advanced esophageal squamous cell carcinoma and contribute to the development of treatment guidelines for esophageal cancer.

Detailed Description

Esophageal cancer (EC) has a higher morbidity and mortality rate than most human malignancies. The standard treatment for unresectable locally advanced esophageal squamous cell carcinoma (ESCC) is concurrent chemoradiotherapy, but survival remains limited. Carrilizumab combined with chemotherapy has been shown to have an excellent pathological remission rate in the treatment of advanced esophageal cancer and locally advanced esophageal cancer. Here, the investigators conducted a phase II, prospective, two-arm clinical study to explore the efficacy of Camrelizumab combined with chemotherapy versus chemoradiotherapy for conversion therapy in potentially resectable advanced esophageal squamous cell carcinoma. All participants meeting the inclusion criteria will be registered after signing the informed consent form. Patients with thoracic esophageal cancer with clinical staging of T4a and T4b or at least one group of lymph nodes likely to invade surrounding organs or with concomitant enlarged lymph nodes unresectable will be included in the study. According to the study plan, patients who completed two cycles of chemotherapy combined with Camrelizumab induction or concurrent chemoradiotherapy were randomly assigned to receive radical surgery after being assessed as operable. The primary endpoint was R0 removal rate in patients undergoing surgery after treatment. Secondary endpoints were major pathological response (MPR) rate, overall survival (OS), progression-free survival (PFS), and adverse events. This study will provide more evidence for the conversion treatment of initially unresectable locally advanced esophageal squamous cell carcinoma and contribute to the development of treatment guidelines for esophageal cancer.

Conditions

Chemotherapy; Radiation Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immumotherapy plus Chemotherapy

Paclitaxel: 175mg/m2, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle (Q3W), a total of 3 cycles.

Cisplatin: 75mg/m2, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle (Q3W), a total of 3 cycles.

Camrelizumab: 200mg was administered intravenously on the first day of each cycle, every 3 weeks as a cycle (Q3W), for a total of 3 cycles.

Group Type: EXPERIMENTAL

Camrelizumab

Intervention Type: DRUG

200mgQ3w

Paclitaxel

Intervention Type: DRUG

175mg/m2，D1，Q3w

Cisplatin

Intervention Type: DRUG

75mg/m2，D1，Q3w

chemoradiotherapy

Paclitaxel: 175mg/m2, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle (Q3W), a total of two cycles

Cisplatin: 75mg/m2, intravenous infusion on the first day of each cycle, every 3 weeks for a cycle (Q3W), a total of two cycles

Radiotherapy: Irradiation mode and dose: three-dimensional conformal or intensity modulated radiotherapy technology was adopted, 41.4Gy, 1.8Gy each time, 5 times a week.

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

175mg/m2，D1，Q3w

Cisplatin

Intervention Type: DRUG

75mg/m2，D1，Q3w

Radiotherapy

Intervention Type: RADIATION

41.4Gy, 1.8Gy each time, 5 times a week

Interventions

Camrelizumab

200mgQ3w

Intervention Type: DRUG

Paclitaxel

175mg/m2，D1，Q3w

Intervention Type: DRUG

Cisplatin

75mg/m2，D1，Q3w

Intervention Type: DRUG

Radiotherapy

41.4Gy, 1.8Gy each time, 5 times a week

Intervention Type: RADIATION

Other Intervention Names

pdl1 Inhibitors; Paclitaxel For Injection (Albumin Bound); Radiation therapy

Eligibility Criteria

Inclusion Criteria

• histologically-confirmed squamous cell carcinoma
• primary lesions located in the thoracic esophagus
• clinical stage cT4 or at least one group of lymph nodes invade the surrounding organs and unresectable lymph nodes
• having not received neoadjuvant therapy
• 18-75 years
• ECOG performance status of 0 or 1
• no prior chemotherapy, radiotherapy, or immunotherapy for any cancers
• adequate organ function
• expectation of R0 resection
• provision of written informed consent.

Exclusion Criteria

• corticosteroid treatment (equivalent to prednisone >10 mg/day) within 14 days before the first day of the drug administration
• acquired immunodeficiency syndrome or active hepatitis B (DNA ≥ 104 copies/ml) or C (RNA ≥ 103 copies/ml) viral infections
• history of pneumonitis or interstitial lung disease with clinical evidence, such as interstitial pneumonia and pulmonary fibrosis features on baseline CT scans
• known or concurrent bleeding disorders or other uncontrolled diseases contraindicating surgical treatment
• physical examination or clinical trial findings that can interfere with the results or put the patient at increased risk for treatment complications
• comorbidities, including chronic pulmonary disease, poorly controlled hypertension, unstable angina, myocardial infarction within 6 months, and unstable mental disorders requiring therapy
• allergy to drugs used in the study
• participation in other clinical trials within 30 days before enrollment
• ineligibility for participation based on the decision of investigators.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University Union Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chun Chen, Prof

Role: STUDY_CHAIR

Key Laboratory of Cardio-Thoracic Surgery, Fujian Medical University, Fujian Province University, Fu

Locations

Fujian Medical University Union Hospital

Fuzhou, , China

Countries

China

Central Contacts

Chun Chen, Prof

Role: CONTACT

chenchun0209@fjmu.edu.cn

13365910325

References

Chen M, Huang Y, Zhang S, Zheng Y, Zeng T, Chen C, Zheng B. Camrelizumab in combination with chemotherapy versus concurrent chemoradiotherapy for the conversion of locally advanced unresectable oesophageal squamous carcinoma: protocol for a two-arm, open-label phase II trial. BMJ Open. 2024 Feb 28;14(2):e075421. doi: 10.1136/bmjopen-2023-075421.

Reference Type: DERIVED

PMID: 38418234 (View on PubMed)

Other Identifiers

I-ICE Union

Identifier Type: -

Identifier Source: org_study_id