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RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2

ConditionAdvanced Gastroesophageal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese PLA General Hospital

About this trial

This study was a single-arm, open, multi-center Phase Ib/II clinical trial to observe and evaluate the efficacy and safety of RC48-ADC plus S-1 in first-line treatment of advanced gastroesophageal adenocarcinoma with moderate expression of HER2.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At the same time, patients voluntarily participated in the study and signed informed consent;

Either male or female, aged 18 or older;

Patients diagnosed by pathological or cytological diagnosis of gastric cancer (GC), gastroesophageal junction carcinoma (GEJ) or esophageal adenocarcinoma had evidence of local advanced lesions or metastases that could not be surgically resected, and were mostly adenocarcinoma confirmed by histological examination;

No previous systemic therapy; Or had received neoadjuvant/adjuvant chemotherapy but experienced disease progression or recurrence 6 months after the end of treatment;

Disqualifiers

Five years before first use of the study drug has been diagnosed as other malignant tumor, the effective treatment of basal cell carcinoma, squamous cell carcinoma of the skin and/or the effective removal of cervical cancer in situ and/or except breast cancer;

Known hypersensitivity to RC48-ADC;

HBV DNA>500 IU/ mL (or 2000 copies /ml), HCV RNA>103 copies /ml, HBsAg+ and anti-HCV antibody positive;

History of HIV infection;

Trial design

Design model

Single group

Treatments tested in this trial

  • RC48-ADC

    Drug

    2.0 mg/kg, IV, d1, every 2 weeks; or 2.5 mg/kg, IV, d1, every 2 weeks

  • S-1

    Drug

    40-60 mg, bid po, d1-10, every 2 weeks

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: RC48-ADC Combined With S-1Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

dose-limiting toxity

Time frame
through study completion, an average of 1 year
2

ORR（Objective Response Rate）

The proportion of patients whose tumors shrink by a certain amount and remain so for a certain amount of time, including CR+PR cases.

Time frame
Imaging tests were performed every 6 weeks (±7 days) from the first year of treatment to assess efficacy, and every 8 weeks (±7 days) after 1 year

Secondary outcomes

1

PFS(progression-free survival)

Time from randomness to the first occurrence of disease progression or death from any cause.

Time frame
Imaging tests were performed every 8 weeks (±7 days) from the first year of treatment to assess efficacy, and every 7 weeks (±7 days) after 1 year
2

DOR(Duration of Response )

DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death

Time frame
Imaging tests were performed every 6 weeks (±7 days) from the first year of treatment to assess efficacy, and every 8 weeks (±7 days) after 1 year
3

OS(Overall Survival)

Time from randomization to death from any cause

Time frame
From date of randomization until the date of death from any cause, assessed up to 24 months
4

AE(Adverse Event)

The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

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

Chinese PLA General Hospital

Lead sponsor

Source ClinicalTrials.gov
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