Nivolumab therapy with DCF chemotherapy

JRCT ID: jRCTs051240130

Registered date:19/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: esophageal cancer
• Date of first enrollment: 19/09/2024
• Target sample size: 25
• Study type: Interventional
• Intervention(s): Nivolumab therapy with DCF chemotherapy

Outcome(s)

• Primary Outcome: ORR; Overall Response Rate

Secondary Outcome

DCR; Disease Control Rate
PFS; Progression-Free Survival
OS; Overall Survival
DoR; Duration of Response
Conversion surgery
irAE

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1. Thoracic esophageal cancer histologically diagnosed as squamous cell carcinoma, adenosquamous cell carcinoma, or basal cell carcinoma
2. Untreated unresectable advanced esophageal cancer (cT4bN0-3M0-1 or cT1-3N0-3M1, UICC-TNM classification 8th edition)
However, Prior perioperative treatment or definitive chemotherapy/radiotherapy/chemoradiotherapy is acceptable if completed before enrollment. However, after completion of therapy, a recurrence-free period of 24 weeks is required for chemotherapy/chemoradiotherapy and 48 weeks for immunotherapy. Endoscopic resection with curative resection (pT1a, ly0, v0) is acceptable as a complete treatment.
3. Patients who are between 20 and 75 years old on the date of registration
4. EOCG Performance Status (PS) 0-1
5. Have one or more measurable lesions based on RECISTver1.1
6. Test values within 14 days before registration

Exclude criteria

1. Having multiple cancers (registration is possible if esophageal cancer determines the prognosis)
2. Have an active systemic infection
3. You have an active autoimmune disease.
However, registration is permitted if you have type I diabetes, a disease that requires only hormone replacement, or a skin disease that does not require systemic treatment.
4. Treatment with systemic corticosteroids (equivalent to prednisone exceeding 10 mg/day; administration of inhaled and topical steroids, and hormone replacement therapy are permissible) or other immunosuppressants (adverse effects for adverse events are permissible). be
5. History of interstitial lung disease or complications
6. Severe cardiac dysfunction
7. The patient does not intend to use contraception or is a pregnant or breastfeeding woman.
8. Patients judged to be unsuitable by the person in charge of this clinical research

Related Information

• Primary Sponsor: Hiroshi Miyata
• Secondary ID(s): Nil known