Adjuvant Treatment of Digestive Tract Tumors

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXijing Hospital

About this trial

To evaluate the 3-year Disease-free survival rate(DFSR) of patients with locally advanced gastric cancer and colorectal cancer treated with anlotinib combined with adjuvant chemotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1.18 years old ≤ age ≤ 75 years old, male or female;

2. ECOG score 0~2 points;

3. Patients with locally advanced gastric cancer and colorectal cancer after radical surgery (R0 resection);

4. Gastric cancer: patients with stage III (pT1N3bM0, pT2N3M0, pT3N2-3M0, pT4aN1-3M0, pT4bN0-3M0);

Disqualifiers

1. Postoperative distal metastasis or failure to achieve R0 resection;

2. Have experienced any anti-tumor treatment before surgery, including chemotherapy, radiotherapy and targeted drug treatment;

3. Patients with contraindications to chemotherapy;

4. Other malignant tumors in the past 3 years;

Trial design

Design model

Single group

Treatments tested in this trial

  • anlotinib+CAPEOX/SOX

    Drug

    Patients with colorectal cancer use the anlotinib+CAPEOX protocol, and patients with gastric cancer use the anlotinib+SOX protocol. Anlotinib: 12mg, administered once a day on day 1-14, taken about half an hour before breakfast (the time of daily administration should be the same as much as possible), delivered with warm water, repeated once every three weeks; CAPEOX: capecitabine 1000mg/m2 each time, oral, twice a day, 1-14 days; Oxaliplatin: 130mg/m2 iv drip d1. SOX: Tegio: 100mg/day, continuous medication for 2 weeks, stop for 1 week; Oxaliplatin: 130mg/m2 iv drip d1.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: anlotinib+CAPEOX/SOXExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

3y-DFSR

3-year Disease-free survival

Time frame
3years

Secondary outcomes

1

DFS

Disease free survival

Time frame
3years
2

3y-OSR

3-year Overall Survival

Time frame
3years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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