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Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients

ConditionsEsophageal Squamous Cell CarcinomaEsophageal NeoplasmsEsophageal DiseasesGastrointestinal NeoplasmsGastrointestinal DiseasesDigestive System NeoplasmsDigestive System DiseasesNeoplasms by SiteNeoplasms by Histologic TypeNeoplasms, Squamous CellCarcinoma, Squamous Cell
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangxi Provincial Cancer Hospital

About this trial

This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma (ESCC) Patients as Postoperative Adjuvant Therapy. In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with TQB2450 Injection in treatment of patients with ESCC. The primary endpoint is disease free survival (DFS).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.

≥ 18 years old.

ECOG performance status of 0-1

Patients with esophageal squamous cell carcinoma pathologically diagnosed as T1-2N1-3M0 or T3-4NanyM0.

Disqualifiers

Patients received other antitumor adjuvant therapy after surgical resection.

Concurrent malignancy (except cured basal cell carcinoma of the skin).

Patients was diagnosed cervical esophageal carcinoma.

Patients who have received prior targeted therapy (anti-VEGF/VEGFR) or immunity therapy (anti-PD-1/PD-L1/CTLA-4).

Trial design

Design model

Single group

Treatments tested in this trial

  • Anlotinib hydrochloride

    Drug

    Anlotinib Hydrochloride is a capsule in the form of 8 mg ,10 mg and 12 mg, orally, once daily, 2 weeks on/1 week off.

  • TQB2450

    Drug

    TQB2450 is an injection in the form of 600 mg; 1200 mg, iv, D1.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: AnlotinibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

DFS

Disease Free Survival

Time frame
DFS was defined as the time from the day patients received first dose of treatment regimen until the date of first documented recurrence or death from any cause, whichever come first, assessed up to 96 months.

Secondary outcomes

1

1-year DFS rate

One year Disease Free Survival rate

Time frame
1-year DFS rate was disease-free survival rate at the time since patients received first dose of treatment regimen for one year.
2

3-year DFS rate

Three year Disease Free Survival rate

Time frame
3-year DFS rate was disease-free survival rate at the time since patients received first dose of treatment regimen for 3 years.
3

1-year OS rate

One year Overall Survival rate

Time frame
1-year OS rate was overall survival rate at the time since patients received first dose of treatment regimen for one year.
4

3-year OS rate

Three year Overall Survival rate

Time frame
3-year OS rate was overall survival rate at the time since patients received first dose of treatment regimen for 3 years.

Other outcomes

Sponsors and contacts

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

Jiangxi Provincial Cancer Hospital

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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