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Camrelizumab Combined With Chemoradiotherapy in Advanced Esophageal Cancer.

ConditionsEsophageal NeoplasmsEsophageal DiseasesDigestive System Neoplasms
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Cancer Hospital

About this trial

This is a prospective single-arm exploratory clinical study. The efficacy and safety of camrelizumab combined with chemoradiotherapy and camrelizumab combined with chemotherapy were evaluated in patients with advanced esophageal cancer who had not previously received any systemic antitumor therapy for esophageal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign written informed consent and voluntarily participate in this study;

Patients with esophageal squamous cell carcinoma confirmed by histopathology and/or immunohistochemistry (8th edition 2017) had UICC/AJCC TNM stage IVA or oligometastatic stage IVB;

Survival is expected to exceed 3 months

Age 18-75;

Disqualifiers

The presence of uncontrollable pleural effusion, pericardial effusion or ascites that require repeated drainage;

Poor nutritional status, BMI < 18.5 Kg/m²; If symptomatic nutritional support was corrected before randomization, enrollment could be considered after evaluation by the principal investigator;

Gastrointestinal bleeding (bleeding volume > 200ml/ day);

Patients with deep ulcers as determined by the investigator;

Trial design

Design model

Single group

Treatments tested in this trial

  • camrelizumab

    Drug

    200mg intravenous drip d1q3w

  • Paclitaxel drugs

    Drug

    150mg/m2 d1 q3w

  • Platinum drug

    Drug

    Cisplatin, carboplatin, nedaplatin and other platinum drugs

  • Radiation

    Radiation

    Dose: 5040cGy/28f

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: drugExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate(ORR)

ORR is determined using RECIST v1.1, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.

Time frame
3 years

Secondary outcomes

1

Overall survival(OS)

Defined as the time from the enrollment to death from any cause

Time frame
3 years
2

Progression free survival(PFS)

It is defined as the time from enrollment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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